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Dysport® Adult Lower Limb Spasticity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249404
First received: November 25, 2010
Last updated: June 30, 2014
Last verified: June 2014
  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 lower limb spasticity due to stroke or traumatic brain injury.


Condition Intervention Phase
Leg Spasticity
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, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With 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 the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Walking speed [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]

Enrollment: 348
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport 1000 U, IM
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Experimental: Dysport 1500 U, IM
1500 U, I.M., on day 1 (single treatment cycle)
Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 (single treatment cycle)
Placebo Comparator: Placebo
I.M., on day 1 (single treatment cycle)
Drug: Placebo
I.M. injection on day 1 (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:

  • Subjects aged 18 to 80 years of age
  • Post stroke or brain injury
  • Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
  • Ambulatory patients

Exclusion Criteria:

  • Fixed contractures
  • Physiotherapy initiated less than 4 weeks before entry
  • Previous surgery or previous treatment with phenol and/or alcohol in lower 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: NCT01249404

  Hide Study Locations
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
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Design Neuroscience Center
Doral, Florida, United States, 33172
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
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, 27599-7200
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
MossRehab & 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 Dallas
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 Medecine
Salt Lake City, Utah, United States, 84132
Australia
Saint Vincent's Hospital
Darlinghurst, Australia
Saint Vincent's Hospital
Fitzroy, Australia
St George Hospital
Kogarah, Australia
Royal Melbourne Hospital
Parkville, Australia
Epworth Rehabilitation
Richmond, Australia
Westmead Hospital
Westmead, Australia
Belgium
Université catholique de Louvain av Hippocrate 10
Bruxelles, Belgium
Clinique Universitaire
Yvoir, Belgium
Czech Republic
Charles University in Prague
Praha 2, Czech Republic
France
CHU Jean MINJOZ
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
Nice, France
Hôpital Sébastopol
Reims, France
Hopital Hautepierre
Strasbourg, France
Nouvel Civil Hospital
Strasbourg, France
Hopital Rangueil
Toulouse, France
Hungary
Uno Medical Trials
Budapest, Hungary
Szent János Hospital
Budapest, Hungary
National Institute for Medical Rehabilitation
Budapest, Hungary
Petz Aladar Country Hospital
Gyor, Hungary
Batthyány Kázmér Hospital
Kisbér, Hungary
Italy
Azienda Ospedaliero
Catania, Italy
SSD Neurofisiologia Riabilitativa
Fossano, Italy
Servizio di Neurofisiologia Clinica-Ospedale San Raffaele
Milano, Italy
Unità Operativa Medicina Riabilitativa
Parma, Italy
Polo IRCCS Eugenio Medea La Nostra Famiglia
Treviso, Italy
Poland
Specjalistyczna Praktyka Lekarska
Katowice, Poland
Centrum Medyczne Plejady
Krakow, Poland
Krakowska Akademia Neurologii
Krakow, Poland
Malopolskie Centrum Medyczne
Krakow, Poland
Nzoz Neuro - Card
Poznan, Poland
Samodzielny Publiczny Centralny Szpinal
Warsaw, Poland
Portugal
Servicio de Rehabilitation de Adultos
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
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: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140, 2009-015868-34
Study First Received: November 25, 2010
Last Updated: June 30, 2014
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: Ministry of Health
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014