Dysport® Adult Upper Limb Spasticity
- Conditions
- Nervous System Disorders
- Interventions
- Drug: PlaceboBiological: Botulinum toxin type A
- Registration Number
- NCT01313299
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- Adult patients - post stroke or brain injury
- Modified Ashworth Scale ≥ 2
- Ambulatory patients
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Dysport 1000 U Botulinum toxin type A - Dysport 500 U Botulinum toxin type A -
- Primary Outcome Measures
Name Time Method Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) From Baseline (Day 1) to Week 4 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.
- Secondary Outcome Measures
Name Time Method Physician's Global Assessment (PGA) of Treatment Response At Week 4 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).
Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) From Baseline (Day 1) to Week 4 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.
Trial Locations
- Locations (39)
Rancho Los Amigos National Rehabilitation Center
🇺🇸Downey, California, United States
Associated Neurologist of Southern CT, PT
🇺🇸Fairfield, Connecticut, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Design Neuroscience Miami
🇺🇸South Miami, Florida, United States
The Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Univ of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Scroll for more (29 remaining)Rancho Los Amigos National Rehabilitation Center🇺🇸Downey, California, United States