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Trial record 1 of 1 for:    y-55-52120-142
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Dysport® Adult Lower Limb Spasticity Follow-on Study

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: November 25, 2010
Last updated: April 28, 2015
Last verified: April 2015
The purpose of this research study is to assess the long term safety of Dysport in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Condition Intervention Phase
Post-stroke Spasticity
Spasticity Post-Traumatic Brain Injury
Drug: Dysport
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower 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 the Modified Ashworth scale [ Time Frame: Every 4 weeks ]
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Every 4 weeks ]
  • Assessment of walking speed [ Time Frame: Every 4 weeks ]

Enrollment: 352
Study Start Date: June 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport
Dysport is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.
Drug: Dysport
I.M. (intramuscular) injection on day 1 of each treatment cycle.


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

Inclusion Criteria:

  • Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)

Exclusion Criteria:

  • Fixed contractures in lower 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: NCT01251367

  Hide Study Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Rancho Los Amigos
Downey, California, United States, 90242
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
United States, Connecticut
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, United States, 06824
United States, Florida
Design Neuroscience Center
Miami, Florida, United States, 33136
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Island Neurological Associates
Plainview, New York, United States, 11803
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7200
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Moss Rehab & Albert Einstein
Elkins Park, Pennsylvania, United States, 19027
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas Southwestern Medical Center at Dalla
Dallas, Texas, United States, 75390-9016
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, United States, 76104
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
St George Hospital
Kogarah, Australia
Epworth Rehabilitation
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
St Vincent's Hospital
Melbourne, Australia
St Vincent's Hospital
Sydney, Australia
Westmead Hospital
Sydney, Australia
Université catholique de Louvain av Hippocrate 10
Bruxelles, Belgium
Clinique Universitaire
Yvoir, Belgium
Czech Republic
Charles University in Prague
Praha 2, Czech Republic
Besançon, France
Centre de Réadaptation de Coubert
Coubert, France
Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
Créteil, France
Hopital Raymond Poincarré
Garches, France
Hôpital de L'Archet I
Nice, France
Hôpital Sébastopol
Reims, France
Hôpital Civil
Strasbourg, France
Hopital Rangueil
Toulouse, France
National Institute for Medical Rehabilitation
Budapest, Hungary
Uno Medical Trials
Budapest, Hungary
Petz Aladar Country Hospital
Gyor, Hungary
Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"
Catania, Italy
Specjalistyczna Praktyka Lekarska
Katowice, Poland
Centrum Medyczne Plejady
Krakow, Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Poland
Malopolskie Centrum Medyczne
Krakow, Poland
Nzoz Neuro - Card
Poznan, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland
Serviço de Reabilitação
Alcabideche, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Centro Hospitalar São João
Porto, Portugal
Russian Federation
Medical Rehabilitation Center
Moscow, Russian Federation
Scientific Research Institute of Neurology
Moscow, Russian Federation
State University
St Petersburg, Russian Federation
Derer's Hospital
Bratislava, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, Slovakia
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01251367     History of Changes
Other Study ID Numbers: Y-55-52120-142
Study First Received: November 25, 2010
Last Updated: April 28, 2015

Additional relevant MeSH terms:
Brain Injuries
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
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 April 21, 2017