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The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport® | Active Comparator | Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only |
|
| Placebo | Placebo Comparator | Placebo, up to 2mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. | The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits. | 4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TWSTRS Total Score at Week 2. | The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Neurology, M.D. | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Movement Disorders Center of Arizona, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33524060 | Derived | Patel AT, Lew MF, Dashtipour K, Isaacson S, Hauser RA, Ondo W, Maisonobe P, Wietek S, Rubin B, Brashear A. Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study. PLoS One. 2021 Feb 1;16(2):e0245827. doi: 10.1371/journal.pone.0245827. eCollection 2021. |
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150 subjects were screened; 16 subjects failed screening. 134 subjects were enrolled (signed informed consent) and were randomised with a 2:1 ratio of Dysport®:placebo. Randomisation was also stratified for subjects who were Botulinum toxin type A (BoNT-A) treatment naive or non-naive at baseline.
First subject enrolled: 7 January 2013; last subject completed: 9 January 2015. 46 investigational sites in the United States of America were planned, 43 sites were initiated and 38 sites enrolled adult subjects with cervical dystonia (CD).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dysport® | Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
| Placebo | Drug | Up to 2mL |
|
| 2 weeks post-treatment |
| Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2. | The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits. | 2 weeks post-treatment |
| TWSTRS Responders at Week 2. | Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100. | 2 weeks post-treatment |
| Change From Baseline in CGIC in CD at Week 4. | The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits. | 4 weeks post-treatment |
| TWSTRS Responders at Week 4. | Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100. | 4 weeks post-treatment |
| Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4. | The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. | 4 weeks post-treatment |
| Change From Baseline in CDIP-58 Total Score at Week 2. | The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect. | 2 weeks post-treatment |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| East Bay Physician's Group | Berkeley | California | 94705 | United States |
| Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| Loma Linda University Healthcare, Department of Neurology | Loma Linda | California | 92354 | United States |
| USC Keck School of Medicine | Los Angeles | California | 90033 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| University of Colorado at Denver Health Sciences | Aurora | Colorado | 80045 | United States |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | United States |
| Associated Neurologists of Southern Connecticut | Fairfield | Connecticut | 06824 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Parkinson's & Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida | 32607 | United States |
| Emerald Coast Center for Neurological Disorders | Pensacola | Florida | 32514 | United States |
| PD Treatment Center of SW FL | Port Charlotte | Florida | 33980 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Guilford Neurologic Associates | West Palm Beach | Florida | 33407 | United States |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Kansas City Bone & Joint Clinic | Kansas City | Kansas | 66211 | United States |
| International Clinical Research Institute | Overland Park | Kansas | 66210 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Rehabilitation Consultants PA | Eagan | Minnesota | 55122 | United States |
| University of Medicine and Dentistry of New Jersey | Stratford | New Jersey | 08084 | United States |
| Atlantic Neuroscience Institute | Summit | New Jersey | 07901 | United States |
| Kingston Neurological Associates | Kingston | New York | 12401 | United States |
| Fazzini Parkinson's Disease & Dystonia Center | New York | New York | 10016 | United States |
| The Ichan School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Island Neurological Associates | Plainview | New York | 11803 | United States |
| Guilford Neurologic Associates; Cone Health Medical Group | Greensboro | North Carolina | 27405 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Physicians Company, LLC | Cincinnati | Ohio | 45267 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| Penn State Hershey Neurology | Hershey | Pennsylvania | 17033 | United States |
| Coastal Neurology | Port Royal | South Carolina | 29935 | United States |
| North Texas Movement Disorders Institute | Bedford | Texas | 76201 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Puget Sound Neurology | Tacoma | Washington | 98409 | United States |
| FG001 | Placebo | Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline characteristics are presented for the Intent to Treat (ITT) Population which consisted of all randomised subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dysport® | Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). |
| BG001 | Placebo | Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. | The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits. | The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks post-treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in TWSTRS Total Score at Week 2. | The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits. | The ITT population consisted of all randomised subjects. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2. | The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits. | The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Responders at Week 2. | Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100. | The ITT population consisted of all randomised subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CGIC in CD at Week 4. | The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits. | The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TWSTRS Responders at Week 4. | Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100. | The ITT population consisted of all randomised subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4. | The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. | The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CDIP-58 Total Score at Week 2. | The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect. | The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks post-treatment |
|
Adverse events (AEs) were collected from the time of informed consent to end of study/early withdrawal (period of up to 13 weeks).
Serious and non-serious treatment emergent AEs (TEAEs) are presented. The safety population consisted of all randomised subjects who received study treatment regardless of the amount of study treatment administered and who had at least one follow up safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dysport® | Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA). | 4 | 88 | 35 | 88 | ||
| EG001 | Placebo | Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®. | 1 | 45 | 10 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA15.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA15.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA15.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Post injection phenomenon | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA15.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA15.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA15.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA15.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA15.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Biopharmaceuticals, Inc. | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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 |
| 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 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 35-44 years |
|
| 45-54 years |
|
| 55-64 years |
|
| 65-74 years |
|
| >75 years |
|
| Male |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| OG001 |
| Placebo |
Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®. |
|
|
|