At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 216 enrolled
Drug / intervention
Botulinum toxin type Abiological
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.
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 in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A for Cerebral Palsy and 2 related conditions. Completed, enrolled 216 participants across 27 sites in 6 countries.
Detailed Summary
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
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 PostedDec 2010
Enrollment StartOct 2011
Primary CompletionJan 2015
TodayJul 2026
First PostedDec 1, 2010
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.6 years ago
Interventions
Botulinum toxin type Abiological
Intramuscular (IM) injection on day 1 of each treatment cycle.