Overview

This trial is active, not recruiting.

Conditions post-stroke spasticity, spasticity post-traumatic brain injury
Treatment dysport
Phase phase 3
Sponsor Ipsen
Start date June 2011
End date July 2015
Trial size 352 participants
Trial identifier NCT01251367, Y-55-52120-142

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
dysport
I.M. (intramuscular) injection on day 1 of each treatment cycle.

Primary Outcomes

Measure
Safety through collection of adverse events
time frame: Every 4 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404) Exclusion Criteria: - Fixed contractures in lower limb

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Ipsen.