Dysport® Adult Upper Limb Spasticity

Completed · Phase 3 · Has a placebo group

Conditions studied: Nervous System Disorders

In brief

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.

Key facts

Study ID

NCT01313299

Run by

Ipsen

People needed

243

Starts

2011-08-01

Expected to finish

2013-09-01

Last updated by the study team

2022-09-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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
• University of Texas — Dallas, Texas, United States
• Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of North Texas HSC — Fort Worth, Texas, United States
• University of Texas — Houston, Texas, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Université catholique de Louvain av Hippocrate 10 — Brussels, Belgium
• Clinique Universitaire — Yvoir, Belgium
• Neurologicka klinika, Olomouc — Olomouc, Czechia
• Charles University in Prague — Prague, Czechia
• CHU Jean MINJOZ — Besançon, France
• CHU Brest — Brest, France
• Centre de Réadaptation de Coubert — Coubert, France
• Centre Hospitalier Albert Chenevier-Hopital Henri Mondor — Créteil, France
• Hopital Raymond Poincarré — Garches, France
• Hôpital Sébastopol — Reims, France

Full record on ClinicalTrials.gov

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