Dysport® Adult Lower Limb Spasticity Study
- Conditions
- Leg Spasticity
- Interventions
- Biological: Botulinum toxin type ADrug: Placebo
- Registration Number
- NCT01249404
- 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 lower limb spasticity due to stroke or traumatic brain injury.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- Subjects aged 18 to 80 years of age
- Post stroke or brain injury
- Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
- Ambulatory patients
- Fixed contractures
- Physiotherapy initiated less than 4 weeks before entry
- Previous surgery or previous treatment with phenol and/or alcohol in lower limb
- Neurological/neuromuscular disorders which may interfere with protocol evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dysport® 1000 U, IM Botulinum toxin type A 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle) Dysport® 1500 U, IM Botulinum toxin type A 1500 U, I.M., on day 1 (single treatment cycle) Placebo Placebo I.M., on day 1 (single treatment cycle)
- Primary Outcome Measures
Name Time Method Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) Baseline and Week 4 Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 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)), 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), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.
- Secondary Outcome Measures
Name Time Method Physician's Global Assesment (PGA) of Treatment Response at Week 4 At Week 4 An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed Baseline and Week 4 Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.
Trial Locations
- Locations (61)
The University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Texas - Houston
🇺🇸Houston, Texas, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Université catholique de Louvain av Hippocrate 10
🇧🇪Bruxelles, Belgium
Epworth Healthcare
🇦🇺Richmond, Australia
Centre Hospitalier Albert Chenevier
🇫🇷Créteil, France
Saint Vincent's Hospital
🇦🇺Fitzroy, Australia
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Uno Medical Trials
🇭🇺Budapest, Hungary
Azienda Ospedaliero
🇮🇹Catania, Italy
Neurorehabilitation Specialist
🇺🇸Houston, Texas, United States
Neurologicka Klinika
🇨🇿Olomouc, Czechia
MossRehab & Albert Einstein
🇺🇸Elkins Park, Pennsylvania, United States
CHU Jean MINJOZ
🇫🇷Besançon, France
University of North Texas HSC at Ben Hogan Center
🇺🇸Fort Worth, Texas, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Pacific Neuroscience Medical Group
🇺🇸Oxnard, California, United States
Associated Neurologists of Southern CT, PC
🇺🇸Fairfield, Connecticut, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Design Neuroscience
🇺🇸Miami Gardens, Florida, United States
Epworth HealthCare
🇦🇺Richmond, Victoria, Australia
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Hôpital de L'Archet
🇫🇷Nice, France
Neurologicka Klinika, VFN
🇨🇿Praha, Czechia
Clinique Universitaire
🇧🇪Yvoir, Belgium
Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan
🇫🇷Brest, France
Nouvel Civil Hospital
🇫🇷Strasbourg, France
Hopital Rangueil
🇫🇷Toulouse, France
Szent János Hospital
🇭🇺Budapest, Hungary
Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
🇮🇹Milano, Italy
National Institute for Medical Rehabilitation
🇭🇺Budapest, Hungary
Krakowska Akademia Neurologii
🇵🇱Krakow, Poland
Polo IRCCS Eugenio Medea La Nostra Famiglia
🇮🇹Treviso, Italy
Petz Aladar Country Hospital
🇭🇺Gyor, Hungary
Specjalistyczna Praktyka Lekarska
🇵🇱Katowice, Poland
Centro Hospitalar Lisboa Norte
🇵🇹Lisbon, Portugal
Servicio de Rehabilitation de Adultos
🇵🇹Alcabideche, Portugal
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Nzoz Neuro - Card
🇵🇱Poznan, Poland
Centro Hospitalar São João
🇵🇹Porto, Portugal
Samodzielny Publiczny Centralny Szpital
🇵🇱Warsaw, Poland
Centre de Réadaptation de Coubert
🇫🇷Coubert, France
Hopital Raymond Poincarré
🇫🇷Garches, France
Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims
🇫🇷Reims, France
Hôpital Sébastopol
🇫🇷Reims, France
Caulfield Hospital
🇦🇺Caulfield, Australia
St George Hospital
🇦🇺Kogarah, Australia
Westmead Hospital
🇦🇺Westmead, Australia
Weill Cornell Medical College
🇺🇸New York, New York, United States
Batthyány Kázmér Hospital
🇭🇺Kisbér, Hungary
Rancho Los Amigos
🇺🇸Downey, California, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Royal Melbourne Hospital
🇦🇺Parkville, Australia
SSD Neurofisiologia Riabilitativa
🇮🇹Fossano, Italy
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Treatments and Rehabilitation Center
🇷🇺Moscow, Russian Federation
St-Petersberg State Medical University
🇷🇺St Petersburg, Russian Federation
Neurologicka klinika, Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Univerzitna Nemocnica Bratislava
🇸🇰Bratislava, Slovakia
State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"
🇷🇺Saint Petersburg, Russian Federation
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
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