At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 212 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, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT® Used In The Treatment Of Upper Limb Spasticity In Children
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A for Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children. Completed, enrolled 212 participants across 31 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, Israel, Mexico, Poland, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionSep 2017
Study CompletionSep 2018
TodayJul 2026
First PostedApr 8, 2014
Enrollment StartApr 1, 2014
Primary CompletionSep 21, 2017
Study CompletionSep 4, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.2 years ago
Interventions
Botulinum toxin type Abiological
Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.