CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
IncobotulinumtoxinA (16-20 Units per kg body weight)drug
Likely dose
IncobotulinumtoxinA (16-20 Units per kg body weight)from 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/NCT01905683
NCT01905683Phase 3Completed
CompareCT.gov

Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin® (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

Merz Pharmaceuticals GmbH·interventional·Posted Jul 23, 2013·Updated Oct 27, 2017

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA (16-20 Units per kg body weight) for Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy. Completed, enrolled 370 participants across 43 sites in 12 countries.

Detailed Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
CountriesAustria, Czechia, Estonia, Germany, Israel, Poland, Romania, Russia, Slovakia, South Korea, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 23, 2013
Enrollment StartAug 1, 2013
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.9 years ago

Interventions

IncobotulinumtoxinA (16-20 Units per kg body weight)drug

Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.