At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 384 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.
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
In Brief
A Phase 3 clinical trial evaluating botulinum toxin Type A and Normal Saline (Placebo) for Pediatrics and 2 related conditions. Completed, enrolled 384 participants across 53 sites in 9 countries.
Detailed Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with 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 StartSep 2012
Primary CompletionJun 2017
TodayJul 2026
First PostedMay 22, 2012
Enrollment StartSep 11, 2012
Primary CompletionJun 28, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.1 years ago
Interventions
botulinum toxin Type Abiological
Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
Normal Saline (Placebo)drug
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.