Dysport® Adult Upper Limb Spasticity

Study Overview
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Brief Summary
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The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

Official Title
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A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

Conditions
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Nervous System Disorders

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients - post stroke or brain injury Modified Ashworth Scale ≥ 2 Ambulatory patients Exclusion Criteria: Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition Physiotherapy initiated less than 4 weeks before inclusion Previous surgery, alcohol, phenol in upper limb Neurological/neuromuscular disorders which may interfere with protocol evaluations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysport 500 U<br> | Biological: Botulinum toxin type A<br>* 500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Experimental: Dysport 1000 U<br> | Biological: Botulinum toxin type A<br>* 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* I.M. (in the muscle) injection on day 1 of a single treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) | MAS scale is used to assess muscle tone using a 6-point scale where: 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 part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5. | From Baseline (Day 1) to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment (PGA) of Treatment Response | PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). | At Week 4 | 
| Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) | DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3. | From Baseline (Day 1) to Week 4 |