Trial record 1 of 1 for:    y-52-52120-145
Previous Study | Return to List | Next Study

Dysport® Adult Upper Limb Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313299
First received: March 10, 2011
Last updated: November 28, 2013
Last verified: November 2013

March 10, 2011
November 28, 2013
August 2011
June 2013   (final data collection date for primary outcome measure)
Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01313299 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dysport® Adult Upper Limb Spasticity
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

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.

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
Nervous System Disorders
  • 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.
  • Drug: Placebo
    I.M. (in the muscle) injection on day 1 of a single treatment cycle.
  • Experimental: Dysport 500 U
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Experimental: Dysport 1000 U
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: Placebo
    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.
 
Completed
243
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   France,   Czech Republic,   Belgium,   Slovakia,   Poland,   Russian Federation,   Hungary
 
NCT01313299
Y-52-52120-145, 2010-019069-28
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
November 2013

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