CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 311 enrolled
Drug / intervention
IncobotulinumtoxinA (16 Units per kg body weight) +2 moredrug
Likely dose
IncobotulinumtoxinA (16 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/NCT01893411
NCT01893411Phase 3Completed
CompareCT.gov

Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin® (incobotulinumtoxinA, NT 201) for the Treatment of Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

Merz Pharmaceuticals GmbH·interventional·Posted Jul 9, 2013·Updated Aug 5, 2021

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA (16 Units per kg body weight), IncobotulinumtoxinA (12 Units per kg body weight), and 1 other intervention for Lower Limb Spasticity Due to Cerebral Palsy. Completed, enrolled 311 participants across 53 sites in 14 countries.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 9, 2013
Enrollment StartJun 1, 2013
Primary CompletionAug 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.0 years ago

Interventions

IncobotulinumtoxinA (16 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 volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.

IncobotulinumtoxinA (12 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 volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.

IncobotulinumtoxinA (4 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 volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.