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Dysport® Adult Upper Limb Spasticity Extension Study

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: March 10, 2011
Last updated: May 7, 2015
Last verified: May 2015
The purpose of this research study is to assess the long term safety of Dysport in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Condition Intervention Phase
Nervous System Disorders
Drug: Botulinum type A toxin (Dysport®)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment 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

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Safety through collection of adverse events [ Time Frame: Every 4 weeks ]

Secondary Outcome Measures:
  • Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Every 4 weeks ]
  • Physician's Global Assessment of treatment response [ Time Frame: Every 4 weeks ]

Enrollment: 258
Study Start Date: November 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport Drug: Botulinum type A toxin (Dysport®)
500 U to 1500 U, I.M. (in the muscle) injection into upper limbs across 4 cycles of treatment with a minimum of 12 weeks between 2 injections.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completion of the double blind study, Y-52-52120-145

Exclusion Criteria:

  • Major limitation in the passive range of motion in upper limb
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01313312

  Hide Study Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
United States, Connecticut
Associated Neurologist of Southern CT, PT
Fairfield, Connecticut, United States, 06824
United States, Florida
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33488
Design Neuroscience Miami
South Miami, Florida, United States, 33143
United States, Illinois
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Univ of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Southwestern Medical Center at Dallas University of Texas
Dallas, Texas, United States, 75390
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, United States, 76104
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
Université catholique de Louvain av Hippocrate 10
Bruxelles, Belgium
Clinique Universitaire
Yvoir, Belgium
Czech Republic
Charles University in Prague
Praha 2, Czech Republic
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
CHU Strasbourg
Strasbourg, France
Hopital Rangueil
Toulouse, France
Petz Aladar County Hospital
Gyor, Budapest, Hungary
National Institute for Medical Rehabilitation
Budapest, Hungary
Azienda Hospedaliero
Catania, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Malopolskie Centrum Medyczne
Krakow, Poland
Krakowska Akademia Neurologii
Warszawa, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland
Russian Federation
Medical Rehabilitation Center
Moscow, Russian Federation
Scientific Center of Neurology of RAMS
Moscow, Russian Federation
State University
St Petersburg, Russian Federation
Derer's Hospital
Bratislava, Slovakia
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01313312     History of Changes
Other Study ID Numbers: Y-52-52120-148
2010-019162-83 ( EudraCT Number )
Study First Received: March 10, 2011
Last Updated: May 7, 2015

Additional relevant MeSH terms:
Nervous System Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on May 25, 2017