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Dysport® Adult Upper Limb Spasticity Extension Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313312
First received: March 10, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of treatment response [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 258
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01313312

  Show 34 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313312     History of Changes
Other Study ID Numbers: Y-52-52120-148, 2010-019162-83
Study First Received: March 10, 2011
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
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
Hungary: MRC-ECCP Regulatory Authority
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014