Clinical Trial: Dysport® Pediatric Lower Limb Spasticity Follow-on Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With DYSPORT® Used in the Treatment of Lower Limb Spasticity i
Brief Summary: The purpose of this research study is to determine whether repeat treatments with Dysport® are safe and effective in the treatment of increased stiffness of the calf muscles and whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
Detailed Summary:
Sponsor: Ipsen
Current Primary Outcome: Safety through collection of Adverse Events [ Time Frame: Every 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- Measurement of progress towards individual therapy [ Time Frame: Every 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Ipsen
Dates:
Date Received: November 25, 2010
Date Started: October 2011
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015
