CompletedPhase 3

Dysport® Pediatric Lower Limb Spasticity Study

United States241 participantsStarted 2011-07

Plain-language summary

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 2 to 17 years with cerebral palsy * Equinus foot position * Ambulatory * Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale Exclusion Criteria: * Fixed contracture * Previous phenol, alcohol injection or surgical intervention * Other neurological / neuromuscular disorder * Severe athetoid or dystonic movements

What they're measuring

Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb

Timeframe: Change from baseline to Week 4

Trial details

NCT IDNCT01249417

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2016-08-30

View on ClinicalTrials.gov More Cerebral Palsy trials