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Dysport® Adult Lower Limb Spasticity Follow-on Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251367
First Posted: December 1, 2010
Last Update Posted: October 17, 2017
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 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: None (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.

  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:

  • 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
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): NCT01251367


  Show 50 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01251367     History of Changes
Other Study ID Numbers: Y-55-52120-142
First Submitted: November 25, 2010
First Posted: December 1, 2010
Last Update Posted: October 17, 2017
Last Verified: April 2015

Additional relevant MeSH terms:
Stroke
Brain Injuries
Brain Injuries, Traumatic
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
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