Dysport® Adult Upper Limb Spasticity Extension Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313312
First received: March 10, 2011
Last updated: May 22, 2014
Last verified: May 2014

March 10, 2011
May 22, 2014
November 2011
January 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 NCT01313312 on ClinicalTrials.gov Archive Site
  • Intensity of muscle tone rated by Modified Ashworth Scale [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of treatment response [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dysport® Adult Upper Limb Spasticity Extension Study
A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment 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 long term safety of Dysport in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nervous System Disorders
Drug: Botulinum type A toxin (Dysport®)
500 U to 1500 U, I.M. (in the muscle) injection into upper limbs across 4 cycles of treatment with a minimum of 12 weeks between 2 injections.
Experimental: Dysport
Intervention: Drug: Botulinum type A toxin (Dysport®)
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
258
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of the double blind study, Y-52-52120-145

Exclusion Criteria:

  • Major limitation in the passive range of motion in upper limb
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
 
NCT01313312
Y-52-52120-148, 2010-019162-83
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
May 2014

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