CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 241 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01249417
NCT01249417Phase 3Completed
CompareCT.gov

A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

Ipsen·interventional·Posted Nov 29, 2010·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Cerebral Palsy and 2 related conditions. Completed, enrolled 241 participants across 29 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Palsy, Muscle Spasticity, Children
CountriesChile, France, Mexico, Poland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2010
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.6 years ago

Interventions

Botulinum toxin type Abiological

I.M. (in the muscle) injection on day 1 of a single treatment cycle.

Placebodrug

I.M. injection on day 1 of a single treatment cycle.