Trial record 1 of 1 for:    y-55-52120-142
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Dysport® Adult Lower Limb Spasticity Follow-on Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01251367
First received: November 25, 2010
Last updated: December 19, 2013
Last verified: December 2013

November 25, 2010
December 19, 2013
June 2011
September 2015   (final data collection date for primary outcome measure)
Safety through collection of adverse events [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01251367 on ClinicalTrials.gov Archive Site
  • Intensity of muscle tone rated by the Modified Ashworth scale [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Physician's global assessment (PGA) of the treatment response [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Assessment of walking speed [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dysport® Adult Lower Limb Spasticity Follow-on Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post-stroke Spasticity
  • Spasticity Post-Traumatic Brain Injury
Drug: Dysport
I.M. (intramuscular) injection on day 1 of each treatment cycle.
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.
Intervention: Drug: Dysport
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
348
December 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)

Exclusion Criteria:

  • Fixed contractures in lower limb
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
 
NCT01251367
Y-55-52120-142
Not Provided
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