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

NCT01905683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2017-10-27

Study results available
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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

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.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Pharmaceuticals GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Austria
  • Czechia
  • Estonia
  • Germany
  • Israel
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905683 on ClinicalTrials.gov