At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 370 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.
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
In Brief
A Phase 3 clinical trial evaluating Botulinum Toxin Type A for Pediatrics and 2 related conditions. Completed, enrolled 370 participants across 56 sites in 9 countries.
Detailed Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatrics, Muscle Spasticity, Cerebral Palsy
CountriesHungary, Italy, Philippines, Poland, Russia, South Korea, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartNov 2012
Primary CompletionAug 2018
TodayJul 2026
First PostedMay 22, 2012
Enrollment StartNov 5, 2012
Primary CompletionAug 25, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.1 years ago
Interventions
Botulinum Toxin Type Abiological
Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.