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Dysport® Adult Upper Limb Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313299
First received: March 10, 2011
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety 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:
  • Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's Global Assessment of treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Upper limb passive function, using the Disability Assessment Scale [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport 500 U Drug: Botulinum type A toxin (Dysport®)
500 U or 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Experimental: Dysport 1000 U Drug: Botulinum type A toxin (Dysport®)
500 U or 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo Comparator: Placebo Drug: Placebo
I.M. (in the muscle) injection on day 1 of a single treatment cycle.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  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 ClinicalTrials.gov identifier: NCT01313299

  Hide Study Locations
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, 33169
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
Dallas, Texas, United States, 75390
University of Texas
Dallas, Texas, United States, 75080
University of North Texas HSC
Fort Worth, Texas, United States, 76104
University of Texas
Houston, Texas, United States, 77030
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
Belgium
Université catholique de Louvain av Hippocrate 10
Bruxelles, Belgium
Clinique Universitaire
Yvoir, Belgium
Czech Republic
Neurologicka klinika, Olomouc
Olomouc, Czech Republic
Charles University in Prague
Praha 2, Czech Republic
France
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
CHU Strasbourg
Strasbourg, France
Hopital Rangueil
Toulouse, France
Hungary
National Institut for Medical Rehabilitation
Budapest, Hungary
Petz Aladar County Hospital
Gyor, Hungary
University of Szeged
Szeged, Hungary
Italy
Azienda Hospedaliero
Catania, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Poland
Malopolskie Centrum Medyczne
Krakow, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland
Krakowska Akademia Neurologii
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
Slovakia
Derer's Hospital
Bratislava, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, Slovakia
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313299     History of Changes
Other Study ID Numbers: Y-52-52120-145, 2010-019069-28
Study First Received: March 10, 2011
Last Updated: November 28, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014