Dysport® Adult Upper Limb Spasticity

Phase 3

Completed

• Conditions: Nervous System Disorders
• Interventions: Drug: Placebo; Biological: 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

Study Timeline

• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-11
• Study Start: 2011-08
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Disposition First Submitted: 2015-05-07
• Disposition First Submitted QC: 2015-05-07
• Disposition First Posted: 2015-05-25
• Results First Submitted: 2015-08-11
• Results First Submitted QC: 2015-09-23
• Results First Posted: 2015-10-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Adult patients - post stroke or brain injury
• Modified Ashworth Scale ≥ 2
• Ambulatory patients

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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

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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)

Petz Aladar County Hospital; 🇭🇺 Gyor, Hungary

Medical Rehabilitation Center; 🇷🇺 Moscow, Russian Federation

Univerzitna nemocnica Bratislava; 🇸🇰 Bratislava, Slovakia

Scientific Center of Neurology of RAMS; 🇷🇺 Moscow, Russian Federation

State University; 🇷🇺 St Petersburg, Russian Federation

Derer's Hospital; 🇸🇰 Bratislava, Slovakia

Krakowska Akademia Neurologii; 🇵🇱 Warszawa, Poland

Parkinson's Disease & Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

The Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States

Azienda Hospedaliero; 🇮🇹 Catania, Italy

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Univ of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Texas; 🇺🇸 Houston, Texas, United States

Hôpital Sébastopol; 🇫🇷 Reims, France

Associated Neurologist of Southern CT, PT; 🇺🇸 Fairfield, Connecticut, United States

Design Neuroscience Miami; 🇺🇸 South Miami, Florida, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Université catholique de Louvain av Hippocrate 10; 🇧🇪 Bruxelles, Belgium

Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Wake Forest Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of North Texas HSC; 🇺🇸 Fort Worth, Texas, United States

University of Utah School of Medicine; 🇺🇸 Salt Lake City, Utah, United States

Clinique Universitaire; 🇧🇪 Yvoir, Belgium

Neurologicka klinika, Olomouc; 🇨🇿 Olomouc, Czechia

CHU Brest; 🇫🇷 Brest, France

Centre de Réadaptation de Coubert; 🇫🇷 Coubert, France

CHU Jean MINJOZ; 🇫🇷 Besançon, France

Malopolskie Centrum Medyczne; 🇵🇱 Krakow, Poland

Centre Hospitalier Albert Chenevier-Hopital Henri Mondor; 🇫🇷 Créteil, France

Charles University in Prague; 🇨🇿 Praha 2, Czechia

Hopital Raymond Poincarré; 🇫🇷 Garches, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Hopital Rangueil; 🇫🇷 Toulouse, France

National Institut for Medical Rehabilitation; 🇭🇺 Budapest, Hungary

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy

University of Szeged; 🇭🇺 Szeged, Hungary

Samodzielny Publiczny Centralny Szpital Kliniczny; 🇵🇱 Warszawa, Poland

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States