A Phase III Study to Evaluate the Efficacy and Safety of... | NCT03261167 | Trialant
NCT03261167
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 2, 2020Actual
Enrollment
124Actual
Phase
Phase 3
Conditions
Spasticity, Post-Stroke
Interventions
Botulinum toxin A (GSK1358820)
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT03261167
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
207660
Secondary IDs
Not provided
Brief Title
A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity
Official Title
A Phase III Study (a Placebo Controlled, Randomized, Double-blind Comparative Study and an Open-label, Uncontrolled Study) to Evaluate the Efficacy and Safety of GSK1358820 in Patients With Post-stroke Upper Limb Spasticity
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2, 2017Actual
Primary Completion Date
Mar 20, 2018Actual
Completion Date
Jan 10, 2019Actual
First Submitted Date
Aug 23, 2017
First Submission Date that Met QC Criteria
Aug 23, 2017
First Posted Date
Aug 24, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 27, 2019
Results First Submitted that Met QC Criteria
Sep 24, 2019
Results First Posted Date
Oct 18, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 22, 2020
Last Update Posted Date
Jun 2, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400 units of botulinum toxin A which can help to increase the maximum dose per administration to 400 units from 240 units as the treatment with 240 units is considered insufficient in subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase followed by open-label phase in which 400 units of the study treatment will be injected in both the groups. The study period will be up to 52 weeks, consisting of a screening phase up to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).
Detailed Description
Not provided
Conditions Module
Conditions
Spasticity, Post-Stroke
Keywords
Botulinum toxin A
Safety
post-stroke upper limb spasticity
Efficacy
GSK1358820
double blind
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Subjects receiving 400 units of botulinum toxin A
Experimental
Subjects will receive a total dose of 400 units of botulinum toxin A of which 240 units will be injected into the muscles that act on finger (including thumb flexors) and wrist flexors, and a total of 160 units will be injected into the muscles that act on the elbow flexors.
Drug: Botulinum toxin A (GSK1358820)
Part 1: Subjects receiving 240 units of botulinum toxin A
Active Comparator
Subjects will receive 240 units of botulinum toxin A injected into the muscles that act on the finger (including thumb flexors) and wrist flexors. Placebo will be injected into the muscles that act on the elbow flexors.
Drug: Botulinum toxin A (GSK1358820)
Drug: Placebo
Part 2,3,4: Subjects receiving 400 units of botulinum toxin A
Experimental
Subjects will receive botulinum toxin A with a dose of 400 units injected in a divided doses.
Drug: Botulinum toxin A (GSK1358820)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Botulinum toxin A (GSK1358820)
Drug
GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6
MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.
Week 6
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12
MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For screening phase (Day -28 to Day -1): Between 20 and 80 years of age at the time of informed consent (ICF).
Subjects with at least a 3-month history of upper limb spasticity after the most recent stroke.
Subjects who have spastic symptoms in the finger (including the thumb), wrist, and elbow flexors whom the investigator considers the injections of 400 units of the product is necessary for the upper limb based on the muscle spasms and the symptoms of the subject.
Subjects who have a previous treatment history of 240 units of the product for the upper limb at least 16 weeks before screening.
Subjects who meet following criteria on MAS at screening (Test position : sitting): at least 3 in for the elbow flexors and at least 2 in the finger or wrist flexors.
Subjects who have severe upper limb spasticity, which deserves to be treated with 400 units of the product in the divided dose and was previously injected 240 units of the product.
Subjects whom the investigator considers that enrolment in the study poses no problems based on the laboratory data results at screening.
Subjects who are free from a history of acute decreased lung function (hospitalization with aggravated asthma/ chronic obstructive pulmonary disease (COPD), pneumonia, or signs of pneumonia, or abnormal reactive airway diseases suggested on X-rays) within the last 3 months at screening and have stable pulmonary function (oxygen saturation [SpO2]value is >=95%).
Body weight >=40 kilograms (kg) at screening.
Male or female subjects will be included. Male subjects must content to use highly effective contraceptive methods and sperm donation must be avoided. Female subjects who are not pregnant or lactating are considered eligible if at least one of the following criteria is met; non-childbearing potential, women of childbearing potential who content to follow the guidance about contraception during the study period and at least for 3 months after the last dose of the product, no plan of pregnancy during the study period.
Subjects who have ability to sign their name on the ICF.
For enrolment in the study (Day 1 [prior to injection]):Subjects who meet the following criteria on MAS score: (Test position : sitting): At least 3 in the elbow flexors and at least 2 in the finger or wrist flexors.
If centrally acting muscle relaxants, tetracycline antibiotics, anticholinergics, benzodiazepines, or benzamides are given, the dose and regimen must be stable at least for the last 2 months before Day 1; Subjects who can maintain the same dosage and regimens at least in the blind phase after initial injection (dose reductions and discontinuation of the drugs are acceptable in the open-label phase. However, second dose increase, resumption, and or new treatment will not be performed).
If intrathecal baclofen is given, the dose and regimen must be stable at least for the last 1 month before Day 1; Subjects who can maintain the same dosage and regimens at least in the blind phase after initial injection (intravenous bolus is not acceptable, dose reductions and discontinuation of the drugs are acceptable. However, second dose increase, resumption, and or new treatment will not be performed).
If antiepileptic agents are given, the dose and regimen must be stable at least for the 1 month before Day 1; Subjects who can maintain the same dose and regimens at least in the blind phase after initial injection (dose reductions and discontinuation of the drugs are acceptable in the open-label phase. However, second dose increase, resumption, and new treatment will not be performed).
If a physical therapy, occupational therapy, or a static splint on the study involvement upper limbs is given, the frequency and treatment regimen must be stable at least for the last 3 weeks before Day 1; Subjects who can maintain the same dose and regimens at least in blind phase (In the open-label phase, the frequency and treatment regimen can be changed depending on the condition of spasticity).
Exclusion Criteria:
For screening phase (Day -28 to Day -1): Subjects present with spasticity requiring treatment in the non-paralytic side of the upper limb.
Subjects who have fixed contracture in the finger (upper limb), wrist, elbow or shoulder muscle, which will be involved in the study.
Subjects who have medically significant capsulitis or subluxation in any one of the fingers (upper limb), wrist, elbow and shoulder, which will be involved in the study, or whom a investigator considers the complicated local signs of pain may affect the efficacy evaluation.
Subjects's upper limb spasticity is attributed to other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, or cerebral palsy).
Subjects who have a 2-fold higher alanine aminotransferase (ALT) level than the upper limit of normal (ULN).
Subjects who have a 1.5-fold higher bilirubin than the ULN (If a bilirubin fractionation shows direct bilirubin < 35%, a 1.5-fold higher free bilirubin than the ULN is acceptable).
Subjects whom the investigator considers presence of a current medical history of unstable liver diseases or biliary tract diseases (the condition will be defined by development of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice or hepatic cirrhosis).
Subjects with corrected QT interval (QTc) > 450 milliseconds (msec) or QTc > 480 msec in subjects with bundle branch block.
Subjects who use peripherally acting muscle relaxants (dantrolene sodium, suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide, etc.) within 1 week of screening.
Subjects who use antibiotic agents with neuromuscular junction inhibitory effects: Aminoglycoside antibiotic agents (streptomycin sulfate, kanamycin sulfate, gentamicin sulfate, neomycin sulfate, spectinomycin hydrochloride, etc.), polypeptides (polymyxin B sulfate), lincomycins (lincomycin hydrochloride, clindamycin), and enviomycin sulfate within 1 week of screening.
Subjects who was diagnosed as having a malignant tumor, or have a history of a malignant tumor within the last 5 years (except completely resected basal cell carcinoma or planocellular carcinoma at least 12 weeks before screening).
Subjects who have participated in another study of an investigational product or other medical research (a clinical study of pharmacotherapy, non-pharmacotherapy, or interventional device) within 30 days before screening, or are currently participating in a study.
Subjects who are concerned likely to have an increased risk for an underlying medical condition/neurological disease due to exposure of the product; subjects who have myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or a serious disease and use of a concomitant drug which may inhibit neuromuscular function.
Subjects with antihuman immunodeficiency virus (HIV) antibody positive.
Subjects who previously experienced allergic reactions or hypersensitivity due to botulinum toxin type A, an additive agent of sodium chloride, or human serum albumin.
Subjects who were previously suspected to have neutralizing antibody production by a investigator during an injection of botulinum toxin type A.
Subjects who have a skin disease such as infection at the site to be injected.
Subjects who suffer from serious and unstable disease, which could pose problems for the safety of subjects and study procedure compliance.
For enrolment in the study (Day 1 [prior to injection]): Subjects who have aspiration pneumonia, relapse of lower respiratory tract infection, uncontrollable asthma, uncontrollable COPD, and/or underlying or a history of serious respiratory dysfunction, which were clinically considered to be respiratory function impairment by a investigator within 12 months before Day 1 visit.
Subjects who have a history of aspiration, or an underlying and/or a history of the symptoms that suggests high risks for aspiration by a investigator within 12 months before Day 1 (serious salivation requiring changing in a type of diet, chronic dysphagia that is difficult to swallow).
Subjects who were treated with botulinum toxin for spasticity of upper limb less than 16 weeks before Day 1 visit.
Subjects who underwent surgical interventions, phenol block, ethanol block or muscle afferent block (MAB) within 12 months before Day 1 visit, or these interventions are planned during the study period in any one of the finger (upper limb), wrist, elbow or shoulder muscles, which will be involved in the study.
Subjects who placed a surgical cast or a dynamic splint within 3 months before Day 1 study visit, and/or these interventions are planned to be placed on the upper limb to be involved in the study.
Subjects who were injected corticosteroid or an anesthetic agent into the finger (upper limb), wrist, or shoulder flexors, which will be involved in the study within 3 months before Day 1 visit, or these injections are planned during the study.
Subjects who received constraint-induced movement therapy (CIMT) within 3 months before Day 1 visit or CIMT is planned during the blind phase.
Subjects who underwent ultrasound therapy, transcutaneous electrical nerve stimulation (TENS) , electrical stimulation therapy, or acupuncture therapy in the upper arm, which will be involved in the study within 1 month before Day 1 visit, or these therapies are planned during the study.
Abo M, Shigematsu T, Hara H, Matsuda Y, Nimura A, Yamashita Y, Takahashi K. Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase. Toxins (Basel). 2020 Feb 18;12(2):127. doi: 10.3390/toxins12020127.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 131 participants were screened of which 7 participants were screen failures [reason being did not meet inclusion exclusion criteria (6) and withdrew consent (1)] and finally 124 participants were randomized (63 participants in the GSK1358820 240 units [U] group and 61 participants in the GSK1358820 400 U group).
Recruitment Details
This was a multicenter study conducted at 40 study centers in Japan, of which 38 centers enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Periods
Title
Milestones
Reasons Not Completed
Double Blind(Treatment cyc1,Upto Week48)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 4, 2017
Jan 17, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will receive either 400 units of botulinum toxin A injection or 240 units of botulinum toxin A injection plus placebo in double blind phase. Eligible subjects for open-label treatment period will receive 400 units of botulinum toxin A injection.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This study will contain a double blind treatment period (Part 1) followed by open-label treatment period (Part 2/Part3/Part4).
Who Masked
ParticipantInvestigator
Part 1: Subjects receiving 240 units of botulinum toxin A
Part 1: Subjects receiving 400 units of botulinum toxin A
Part 2,3,4: Subjects receiving 400 units of botulinum toxin A
Placebo
Drug
Placebo injection will contain sodium chloride (0.9 mg).
Part 1: Subjects receiving 240 units of botulinum toxin A
Week 2, Week 4, Week 6 and Week 12
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])
The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12
The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
Up to 84 days post first treatment
Number of Participants With AEs and SAEs-Overall Study Period
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
Up to Week 48
Number of Participants With Abnormal Findings After Physical Examinations
Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.
Up to Week 48
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
Up to Week 48
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
Up to Week 48
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis
Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
Up to Week 48
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48
Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Baseline (Day 1), Week 12 and Week 48
Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48
Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Baseline (Day 1), Week 12 and Week 48
Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48
Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Baseline (Day 1), Week 12 and Week 48
Aichi
490-1405
Japan
GSK Investigational Site
Chiba
277-8567
Japan
GSK Investigational Site
Chiba
279-0021
Japan
GSK Investigational Site
Fukui
910-0067
Japan
GSK Investigational Site
Fukuoka
819-8551
Japan
GSK Investigational Site
Hiroshima
720-0825
Japan
GSK Investigational Site
Hiroshima
734-8530
Japan
GSK Investigational Site
Hokkaido
005-0802
Japan
GSK Investigational Site
Hyōgo
651-2181
Japan
GSK Investigational Site
Ibaraki
300-0028
Japan
GSK Investigational Site
Ibaraki
312-0057
Japan
GSK Investigational Site
Kagoshima
890-0067
Japan
GSK Investigational Site
Kanagawa
227-8518
Japan
GSK Investigational Site
Kanagawa
232-0024
Japan
GSK Investigational Site
Kanagawa
245-8560
Japan
GSK Investigational Site
Kanagawa
259-1143
Japan
GSK Investigational Site
Kochi
780-0051
Japan
GSK Investigational Site
Kumamoto
862-0924
Japan
GSK Investigational Site
Nagano
399-6461
Japan
GSK Investigational Site
Niigata
945-8585
Japan
GSK Investigational Site
Okayama
703-8265
Japan
GSK Investigational Site
Osaka
538-0044
Japan
GSK Investigational Site
Osaka
570-8507
Japan
GSK Investigational Site
Osaka
580-0032
Japan
GSK Investigational Site
Ōita
870-0862
Japan
GSK Investigational Site
Saga
849-8501
Japan
GSK Investigational Site
Shizuoka
417-0801
Japan
GSK Investigational Site
Shizuoka
433-8511
Japan
GSK Investigational Site
Tokushima
770-8503
Japan
GSK Investigational Site
Tokyo
102-8798
Japan
GSK Investigational Site
Tokyo
105-8471
Japan
GSK Investigational Site
Tokyo
123-0853
Japan
GSK Investigational Site
Tokyo
165-8906
Japan
GSK Investigational Site
Tokyo
192-0032
Japan
GSK Investigational Site
Tokyo
201-8601
Japan
GSK Investigational Site
Wakayama
641-8509
Japan
GSK Investigational Site
Yamagata
992-0057
Japan
FG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
FG00063 subjects
FG00161 subjects
COMPLETED
FG00060 subjects
FG00157 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
Open-label(Treatment cycle2,Upto Week48)
Type
Comment
Milestone Data
STARTED
Participants who met retreatment criteria in Treatment cycle 1 and received second dose
FG00060 subjects
FG00157 subjects
COMPLETED
FG00058 subjects
FG00157 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
Type
Comment
Reasons
Protocol defined stopping criteria
FG0001 subjects
FG0010 subjects
Withdrawal by Subject
FG0001 subjects
FG001
Open-label(Treatment cycle3,Upto Week48)
Type
Comment
Milestone Data
STARTED
Participants who met retreatment criteria in Treatment cycle 2 and received third dose
FG00055 subjects
FG00156 subjects
COMPLETED
FG00054 subjects
FG00155 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
Open-label(Treatment cycle4,Upto Week48)
Type
Comment
Milestone Data
STARTED
Participants who met retreatment criteria in Treatment cycle 3 and received fourth dose
FG00043 subjects
FG00140 subjects
COMPLETED
FG00043 subjects
FG00140 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
BG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00063
BG00161
BG002124
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00057.3± 10.98
BG00157.1± 9.90
BG00257.2± 10.42
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00115
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese/East Asian Heritage (AH)/South East AH
Title
Measurements
BG00063
BG00160
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6
MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.
Intent to treat 1 (ITT1) Population comprised of participants who were randomized in the study and who had at least 1 post-baseline efficacy assessment.
Posted
Number
Percentage of participants
Week 6
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Title
Measurements
OG00050.8
OG00168.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference
18.1
2-Sided
95
1.1
35.0
Other
Secondary
Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12
MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.
ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Posted
Number
Percentage of participants
Week 2, Week 4, Week 6 and Week 12
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])
The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
ITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12
The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
Safety1 Population. Safety1 Population comprised of all participants who were randomized in the study and who receive study treatment at least once.
Posted
Count of Participants
Participants
Up to 84 days post first treatment
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With AEs and SAEs-Overall Study Period
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.
Safety1 Population
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With Abnormal Findings After Physical Examinations
Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.
Safety1 Population. This analysis was not planned and data was not collected and captured in the database.
Posted
Up to Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
Safety1 Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.
Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis
Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
OG001
Secondary
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48
Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Millimeters of mercury
Baseline (Day 1), Week 12 and Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48
Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Beats per minute
Baseline (Day 1), Week 12 and Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Secondary
Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48
Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.
Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Degree Celsius
Baseline (Day 1), Week 12 and Week 48
ID
Title
Description
OG000
GSK1358820 240 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of matching placebo was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles [cyc] 2, 3 and 4). Participants were re-treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Time Frame
Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase.
Description
Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
GSK1358820 240 U (Double Blind-Treatment Cycle 1)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.
0
63
4
63
19
63
EG001
GSK1358820 400 U (Double Blind-Treatment Cycle 1)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase.
1
61
5
61
24
61
EG002
GSK1358820 240 U (Open Label-Treatment Cycle 2)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).
0
60
1
60
7
60
EG003
GSK1358820 400 U (Open labelTreatment Cycle 2)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2).
0
57
2
57
11
57
EG004
GSK1358820 240 U (Open Label-Treatment Cycle 3)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments.
0
55
2
55
12
55
EG005
GSK1358820 400 U (Open Label-Treatment Cycle 3)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments.
0
56
1
56
6
56
EG006
GSK1358820 240 U (Open Label-Treatment Cycle 4)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
0
43
0
43
7
43
EG007
GSK1358820 400 U (Open Label-Treatment Cycle 4)
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments.
0
40
2
40
13
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG0030 affected57 at risk
EG0040 affected55 at risk
EG0051 affected56 at risk
EG0060 affected43 at risk
EG0071 affected40 at risk
Lung infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Decreased activity
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00011 affected63 at risk
EG0017 affected61 at risk
EG0022 affected60 at risk
EG0031 affected57 at risk
EG0044 affected55 at risk
EG0050 affected56 at risk
EG0062 affected43 at risk
EG0073 affected40 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0003 affected63 at risk
EG0017 affected61 at risk
EG0024 affected60 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0014 affected61 at risk
EG0023 affected60 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 affected63 at risk
EG0013 affected61 at risk
EG0020 affected60 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Joint swelling
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Nodule
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0002 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 affected63 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0002 affected63 at risk
EG0013 affected61 at risk
EG0020 affected60 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0022 affected60 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0003 affected63 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0013 affected61 at risk
EG0020 affected60 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0013 affected61 at risk
EG0020 affected60 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 affected63 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Elbow Flexion, Week 2, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00044.4
OG00177.0
Elbow Flexion, Week 4, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00052.4
OG001
Elbow Flexion, Week 6, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00050.8
OG001
Elbow Flexion, Week 12, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00033.3
OG001
Wrist Flexion, Week 2, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00077.8
OG001
Wrist Flexion, Week 4, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00082.5
OG001
Wrist Flexion, Week 6, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00081.0
OG001
Wrist flexion, Week 12, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00054.0
OG001
Finger Flexion, Week 2, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00087.3
OG001
Finger Flexion, Week 4, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00085.7
OG001
Finger Flexion, Week 6, n=63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00081.0
OG001
Finger Flexion, Week 12, n =63,61
ParticipantsOG00063
ParticipantsOG00161
Title
Measurements
OG00046.0
OG001
Thumb Flexion, Week 2, n=60,54
ParticipantsOG00060
ParticipantsOG00154
Title
Measurements
OG00075.0
OG001
Thumb Flexion, Week 4, n=60,54
ParticipantsOG00060
ParticipantsOG00154
Title
Measurements
OG00071.7
OG001
Thumb Flexion, Week 6, n=60,54
ParticipantsOG00060
ParticipantsOG00154
Title
Measurements
OG00068.3
OG001
Thumb flexion, Week 12,n=60,54
ParticipantsOG00060
ParticipantsOG00154
Title
Measurements
OG00046.7
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted rate difference
33.1
2-Sided
95
17.0
49.2
Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
21.7
2-Sided
95
4.9
38.5
Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
18.4
2-Sided
95
1.3
35.5
Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
12.9
2-Sided
95
-4.2
30.1
Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-5.6
2-Sided
95
-20.9
9.8
Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-8.6
2-Sided
95
-23.0
5.9
Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-12.1
2-Sided
95
-27.5
3.2
Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-9.6
2-Sided
95
-27.2
7.9
Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-8.6
2-Sided
95
-21.9
4.7
Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-10.4
2-Sided
95
-24.3
3.4
Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-8.9
2-Sided
95
-23.8
6.0
Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-0.1
2-Sided
95
-17.7
17.4
Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-9.9
2-Sided
95
-26.4
6.5
Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-6.7
2-Sided
95
-23.6
10.3
Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-1.5
2-Sided
95
-18.8
15.7
Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG000
OG001
Adjusted rate difference
-0.5
2-Sided
95
-18.8
17.9
Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.
Other
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Elbow Flexion, Week 2, n=63,60
ParticipantsOG00063
ParticipantsOG00160
Title
Measurements
OG000-0.59± 0.089
OG001-1.07± 0.102
Elbow Flexion, Week 4, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-0.7± 0.097
OG001
Elbow Flexion, Week 6, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-0.71± 0.107
OG001
Elbow Flexion, Week 12, n=60,57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG000-0.35± 0.072
OG001
Wrist Flexion, Week 2, n=63,60
ParticipantsOG00063
ParticipantsOG00160
Title
Measurements
OG000-1.29± 0.120
OG001
Wrist Flexion, Week 4, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-1.45± 0.122
OG001
Wrist Flexion, Week 6, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-1.29± 0.115
OG001
Wrist flexion, Week 12, n=60,57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG000-0.69± 0.097
OG001
Finger Flexion, Week 2, n=63,60
ParticipantsOG00063
ParticipantsOG00160
Title
Measurements
OG000-1.38± 0.113
OG001
Finger Flexion, Week 4, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-1.49± 0.117
OG001
Finger Flexion, Week 6, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-1.36± 0.118
OG001
Finger Flexion, Week 12, n=60,57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG000-0.63± 0.116
OG001
Thumb Flexion, Week 2, n=60,53
ParticipantsOG00060
ParticipantsOG00153
Title
Measurements
OG000-1.24± 0.123
OG001
Thumb Flexion, Week 4, n=60,53
ParticipantsOG00060
ParticipantsOG00153
Title
Measurements
OG000-1.29± 0.127
OG001
Thumb Flexion, Week 6, n=60,53
ParticipantsOG00060
ParticipantsOG00153
Title
Measurements
OG000-1.12± 0.119
OG001
Thumb flexion, Week 12, n=57,51
ParticipantsOG00057
ParticipantsOG00151
Title
Measurements
OG000-0.69± 0.133
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Net)
-0.48
2-Sided
95
-0.75
-0.22
Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.42
2-Sided
95
-0.71
-0.13
Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.37
2-Sided
95
-0.71
-0.04
Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.27
2-Sided
95
-0.51
-0.02
Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.08
2-Sided
95
-0.27
0.42
Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.11
2-Sided
95
-0.25
0.46
Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.02
2-Sided
95
-0.37
0.33
Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.09
2-Sided
95
-0.19
0.38
Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.10
2-Sided
95
-0.23
0.43
Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.17
2-Sided
95
-0.17
0.52
Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.14
2-Sided
95
-0.20
0.48
Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.05
2-Sided
95
-0.25
0.34
Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.28
2-Sided
95
-0.08
0.63
Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.14
2-Sided
95
-0.23
0.51
Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.03
2-Sided
95
-0.33
0.38
Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
0.08
2-Sided
95
-0.31
0.47
Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Week 2, n=63,60
ParticipantsOG00063
ParticipantsOG00160
Title
Measurements
OG000-0.34± 0.087
OG001-0.59± 0.085
Week 4, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-0.46± 0.096
OG001
Week 6, n=63,59
ParticipantsOG00063
ParticipantsOG00159
Title
Measurements
OG000-0.52± 0.081
OG001
Week 12, n=60,57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG000-0.35± 0.082
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Net)
-0.24
2-Sided
95
-0.48
0.00
Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.16
2-Sided
95
-0.42
0.09
Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.15
2-Sided
95
-0.37
0.08
Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG000
OG001
Mean Difference (Net)
-0.28
2-Sided
95
-0.52
-0.04
Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.
Other
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Any AE
Title
Measurements
OG00029
OG00131
Any SAE
Title
Measurements
OG0004
OG0015
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Any AE
Title
Measurements
OG00052
OG00149
Any SAE
Title
Measurements
OG0006
OG0018
Units
Counts
Participants
OG0000
OG0010
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00062
OG00159
Title
Denominators
Categories
Eosinophils, To high
Title
Measurements
OG0007
OG0013
Hemoglobin, To low
Title
Measurements
OG0005
OG0015
Hemoglobin, To high
Title
Measurements
OG0001
OG0015
Hematocrit, To low
Title
Measurements
OG0005
OG0015
Hematocrit, To high
Title
Measurements
OG0004
OG0016
Lymphocytes, To low
Title
Measurements
OG00011
OG00111
Lymphocytes, To high
Title
Measurements
OG0000
OG0011
Mean corpuscle hemoglobin, To low
Title
Measurements
OG0002
OG0011
Mean corpuscle hemoglobin, To high
Title
Measurements
OG0001
OG0013
Mean corpuscle volume, To low
Title
Measurements
OG0003
OG0010
Mean corpuscle volume, To high
Title
Measurements
OG0001
OG0012
Monocytes, To high
Title
Measurements
OG0000
OG0014
Total neutrophils, To low
Title
Measurements
OG0000
OG0011
Total neutrophils, To high
Title
Measurements
OG0006
OG00111
Platelet count, To low
Title
Measurements
OG0002
OG0011
Platelet count, To high
Title
Measurements
OG0007
OG0014
Red blood cell count, To low
Title
Measurements
OG0002
OG0012
Red blood cell count, To high
Title
Measurements
OG0002
OG0017
Reticulocytes, To high
Title
Measurements
OG0004
OG0015
White blood cell count, To low
Title
Measurements
OG0000
OG0011
White blood cell count, To high
Title
Measurements
OG0003
OG0013
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00062
OG00159
Title
Denominators
Categories
Alkaline Phosphatase, High
Title
Measurements
OG0005
OG0016
Alanine amino transferase, High
Title
Measurements
OG0008
OG0016
Aspartate amino transferase, High
Title
Measurements
OG0003
OG0012
Direct bilirubin, High
Title
Measurements
OG0001
OG0012
Total bilirubin, High
Title
Measurements
OG0000
OG0012
Calcium, Low
Title
Measurements
OG0000
OG0011
Creatinine, Low
Title
Measurements
OG0005
OG0011
Creatinine, High
Title
Measurements
OG0003
OG0012
Potassium, Low
Title
Measurements
OG0001
OG0011
Potassium, High
Title
Measurements
OG0001
OG0011
Sodium, Low
Title
Measurements
OG0005
OG0012
Sodium, High
Title
Measurements
OG0001
OG0010
Total protein, Low
Title
Measurements
OG00011
OG00114
Total protein, High
Title
Measurements
OG0001
OG0011
Urea/BUN, Low
Title
Measurements
OG0002
OG0013
Urea/BUN, High
Title
Measurements
OG0007
OG0015
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
Occult blood, Any increase
Title
Measurements
OG00011
OG00111
Occult blood, Increase to trace
Title
Measurements
OG0004
OG0012
Occult blood, Increase to 1+
Title
Measurements
OG0002
OG0017
Occult blood, Increase to 2+
Title
Measurements
OG0001
OG0012
Occult blood, Increase to 3+
Title
Measurements
OG0004
OG0010
Protein, Any increase
Title
Measurements
OG0009
OG00114
Protein, Increase to trace
Title
Measurements
OG0004
OG00111
Protein, Increase to 1+
Title
Measurements
OG0004
OG0012
Protein, Increase to 2+
Title
Measurements
OG0001
OG0010
Protein, Increase to 3+
Title
Measurements
OG0000
OG0011
Protein, Increase to 4+
Title
Measurements
OG0000
OG0010
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
SBP, Week 12; n=60, 57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG0000.8± 11.29
OG0011.3± 11.19
DBP, Week 12; n=60, 57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG0000.5± 8.01
OG001
SBP, Week 48; n=57, 56
ParticipantsOG00057
ParticipantsOG00156
Title
Measurements
OG000-1.6± 13.85
OG001
DBP, Week 48; n=57, 56
ParticipantsOG00057
ParticipantsOG00156
Title
Measurements
OG000-1.8± 10.01
OG001
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.
Units
Counts
Participants
OG00063
OG00161
Title
Denominators
Categories
Week 12; n=60, 57
ParticipantsOG00060
ParticipantsOG00157
Title
Measurements
OG0000.2± 9.95
OG0012.6± 8.20
Week 48; n=57, 56
ParticipantsOG00057
ParticipantsOG00156
Title
Measurements
OG0000.5± 10.05
OG001
OG001
GSK1358820 400 U
Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist (Flexor carpi radialis [B1], Flexor carpi ulnaris [B2]), finger (Flexor digitorum profundus [C1], Flexor digitorum superficialis [C2]), thumb (Flexor pollicis longus [D1], Adductor pollicis [D2]) and a single dose of GSK1358820 160 U was injected into the muscles that acted on elbow flexors Biceps brachii [A1], Brachialis [A2], Brachioradialis [A3] during the double-blind phase. Participants who met the re-treatment criteria between Week 12 to 36 were treated with GSK1358820 400 U injections in the open-label phase (one injection each in Treatment cycles 2, 3 and 4). Participants were treated up to 3 times with an interval of 12 weeks between treatments during the open-label phase.