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Dysport® Adult Upper Limb Spasticity

This study is currently recruiting participants.
Verified March 2013 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313299
First received: March 10, 2011
Last updated: March 31, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 228
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313299

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 40 Study Locations
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: March 31, 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:
Muscle Spasticity
Nervous System Diseases
Brain Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
 Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013