Dysport® Adult Lower Limb Spasticity Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01249404
First received: November 25, 2010
Last updated: December 19, 2013
Last verified: December 2013

November 25, 2010
December 19, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Change from baseline at week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249404 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dysport® Adult Lower Limb Spasticity Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Leg Spasticity
  • Drug: Botulinum type A toxin (Dysport®)
    I.M. injection on day 1 (single treatment cycle)
  • Drug: Placebo
    I.M. injection on day 1 (single treatment cycle)
  • Experimental: Dysport 1000 U, IM
    1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Experimental: Dysport 1500 U, IM
    1500 U, I.M., on day 1 (single treatment cycle)
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: Placebo
    I.M., on day 1 (single treatment cycle)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
348
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Czech Republic,   France,   Hungary,   Italy,   Poland,   Portugal,   Russian Federation,   Slovakia
 
NCT01249404
Y-55-52120-140, 2009-015868-34
Yes
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP