NCT01905683

Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (16-20 Units per kg body weight)	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-07-23
• Last updated: 2017-10-27
• Results posted: 2017-10-27

Locations

43 sites across 12 countries: Austria, Czechia, Estonia, Germany, Israel, Poland, Romania, Russia, Slovakia, South Korea, Turkey (Türkiye), Ukraine