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Dysport® Adult Lower Limb Spasticity Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249404
First Posted: November 29, 2010
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Week 4 ]
  • Walking speed [ Time Frame: Change from baseline at week 4 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249404


  Show 57 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01249404     History of Changes
Other Study ID Numbers: Y-55-52120-140
2009-015868-34 ( EudraCT Number )
First Submitted: November 25, 2010
First Posted: November 29, 2010
Last Update Posted: June 19, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
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


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