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The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Dysport® 500U intramuscular injection |
|
| Placebo Group | Placebo Comparator | Placebo intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms | The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity. | From Week 4 up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in MAS of the Primary Targeted Muscle Group. | Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject's last study visit) of the MAS score is reported. |
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Inclusion Criteria:
2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)
Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke
Presence of spasticity:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Laboratory -University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia | |||
| Center for Neurodiagnostic and Therapeutic Services Metropolitan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29933562 | Derived | Rosales RL, Balcaitiene J, Berard H, Maisonobe P, Goh KJ, Kumthornthip W, Mazlan M, Latif LA, Delos Santos MMD, Chotiyarnwong C, Tanvijit P, Nuez O, Kong KH. Early AbobotulinumtoxinA (Dysport(R)) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study. Toxins (Basel). 2018 Jun 21;10(7):253. doi: 10.3390/toxins10070253. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
The first visit was scheduled within 2 to 12 weeks post-stroke and subjects were randomized at a ratio of 2:1 to receive either Dysport® 500 Units (U) or placebo. Dysport® was expected to have a beneficial effect in these subjects so the unbalanced randomisation ratio was chosen in order to expose the minimum number of subjects to inactive placebo.
A total of 42 adult subjects with upper limb (UL) spasticity were enrolled into a multicentre, prospective, double-bind, randomised, placebo-controlled pilot study, conducted in four countries (Malaysia, Thailand, Singapore, and the Philippines).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport ® 500 U | Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL). Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| FG001 | Placebo | Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for the 42 subjects with UL spasticity who were enrolled and treated with either Dysport® 500 U or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dysport ® 500 U | Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL. Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms | The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity. | This analysis was performed on the Intention-To-Treat (ITT) population which includes all randomised subjects who provided informed consent. | Posted | Median | 95% Confidence Interval | days | From Week 4 up to Week 28 |
Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dysport ® 500 U | Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL. Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director, Neurology | Ipsen | clinical.trials@ipsen.com |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug | Placebo administered intramuscularly in the targeted upper limb. |
|
| From baseline up to Week 28 |
| Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment. | The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria: A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6) Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported. Higher values for change from baseline indicated a better outcome. | From baseline up to Week 28 |
| Global Assessment of Changes at Last Visit | Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity. | From Week 4 up to Week 28 |
| Number of Concomitant Non-drug Therapy Sessions. | The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of "Post Stroke UL Spasticity" were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date. | From baseline up to Week 28 |
| Mean Duration of Concomitant Non-drug Therapy Sessions. | The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of "Post Stroke UL Spasticity" was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date. | From baseline up to Week 28 |
| Manila |
| 1003 |
| Philippines |
| TTSH Rehabilitation Centre Ang Mo Kio Community Hospital | Singapore | 569766 | Singapore |
| Department of rehabilitation Medicine Faculty of medicine Siriraj Hospital, Madihol University Hospital | Bangkok | 10700 | Thailand |
| BG001 | Placebo | Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| BG002 | Total Title |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Country | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Dysport ® 500 U | Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL. Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
| OG001 | Placebo | Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. |
|
|
|
| Secondary | Mean Change in MAS of the Primary Targeted Muscle Group. | Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject's last study visit) of the MAS score is reported. | This analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. | Posted | Least Squares Mean | Standard Error | units on a scale | From baseline up to Week 28 |
|
|
|
|
| Secondary | Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment. | The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria: A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6) Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported. Higher values for change from baseline indicated a better outcome. | This analysis was performed on the ITT population and includes all randomised subjects who provided informed consent. | Posted | Least Squares Mean | Standard Error | units on a scale | From baseline up to Week 28 |
|
|
|
|
| Secondary | Global Assessment of Changes at Last Visit | Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?
Results are reported overall for subjects with both symptomatic and asymptomatic spasticity. | This efficacy analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. No data is available for subjects who met their reinjection criteria at Visit 2 (Week 4). | Posted | Number | percentage of participants | From Week 4 up to Week 28 |
|
|
|
|
| Secondary | Number of Concomitant Non-drug Therapy Sessions. | The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of "Post Stroke UL Spasticity" were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date. | This analysis was performed on the safety population which includes all randomised subjects who received the study medication. | Posted | Number | Number of sessions | From baseline up to Week 28 |
|
|
|
| Secondary | Mean Duration of Concomitant Non-drug Therapy Sessions. | The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of "Post Stroke UL Spasticity" was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date. | This analysis was performed on the safety population which includes all randomised subjects who received the study medication. | Posted | Mean | Standard Deviation | days | From baseline up to Week 28 |
|
|
|
| 0 |
| 28 |
| 3 |
| 28 |
| 5 |
| 28 |
| EG001 | Placebo | Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit. | 0 | 14 | 0 | 14 | 4 | 14 |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the first communication or publication regarding the study must be a joint publication between the PI and Sponsor.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Visit 3 (Week 6) |
|
|
| Visit 4 (Week 8) |
|
|
| Visit 5 (Week 10) |
|
|
| Visit 6 (Week12) |
|
|
| Visit 7 (Week 16) |
|
|
| Visit 8 (Week 20) |
|
|
| Visit 9 (Week 24) |
|
|
| Visit 10 (Week 28) |
|
|
| Differences between treatment groups at Visit 3 (Week 6). | ANOVA | 0.0007 | p value significance level = 5% | Mean Difference (Final Values) | -1.05 | 2-Sided | 95 | -1.63 | -0.47 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 4 (Week 8). | ANOVA | 0.0006 | p value significance level = 5% | Mean Difference (Final Values) | -1.05 | 2-Sided | 95 | -1.62 | -0.48 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 5 (Week 10). | ANOVA | 0.0027 | p value significance level = 5% | Mean Difference (Final Values) | -0.84 | 2-Sided | 95 | -1.36 | -0.31 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 6 (Week 12). | ANOVA | 0.0052 | p value significance level = 5% | Mean Difference (Final Values) | -0.83 | 2-Sided | 95 | -1.39 | -0.26 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 7 (Week 16). | ANOVA | 0.2037 | p value significance level = 5% | Mean Difference (Final Values) | -0.52 | 2-Sided | 95 | -1.35 | 0.31 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 8 (Week 20). | ANOVA | 0.7656 | p value significance level = 5% | Mean Difference (Final Values) | -0.15 | 2-Sided | 95 | -1.25 | 0.94 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 9 (Week 24). | ANOVA | 0.8521 | p value significance level = 5% | Mean Difference (Final Values) | -0.12 | 2-Sided | 95 | -1.46 | 1.23 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 10 (Week 28). | ANOVA | 0.6582 | p value significance level = 5% | Mean Difference (Final Values) | -0.21 | 2-Sided | 95 | -1.24 | 0.81 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Visit 3 (Week 6) |
|
|
| Visit 4 (Week 8) |
|
|
| Visit 5 (Week 10) |
|
|
| Visit 6 (Week 12) |
|
|
| Visit 7 (Week 16) |
|
|
| Visit 8 (Week 20) |
|
|
| Visit 9 (Week 24) |
|
|
| Visit 10 (Week 28) |
|
|
| Differences between treatment groups at Visit 3 (Week 6). | ANOVA | 0.8805 | p value significance level = 5% | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -12.8 | 11.1 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 4 (Week 8). | ANOVA | 0.6992 | p value significance level = 5% | Mean Difference (Final Values) | -2.2 | 2-Sided | 95 | -14.0 | 9.6 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 5 (Week 10). | ANOVA | 0.9882 | p value significance level = 5% | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -13.0 | 12.8 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 6 (Week 12). | ANOVA | 0.5646 | p value significance level = 5% | Mean Difference (Final Values) | 4.6 | 2-Sided | 95 | -11.9 | 21.2 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 7 (Week 16). | ANOVA | 0.2325 | p value significance level = 5% | Mean Difference (Final Values) | -12.5 | 2-Sided | 95 | -34.0 | 9.0 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 8 (Week 20). | ANOVA | 0.2441 | p value significance level = 5% | Mean Difference (Final Values) | -14.1 | 2-Sided | 95 | -39.4 | 11.1 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 9 (Week 24). | ANOVA | 0.4311 | p value significance level = 5% | Mean Difference (Final Values) | -9.0 | 2-Sided | 95 | -33.7 | 15.7 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| Differences between treatment groups at Visit 10 (Week 28). | ANOVA | 0.7310 | p value significance level = 5% | Mean Difference (Final Values) | -4.5 | 2-Sided | 95 | -33.3 | 24.3 | Other | Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1. |
| No Change |
|
| Worse |
|
| Much Worse |
|
| Other therapies |
|
| Other therapies |
|