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Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children

NCT02106351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2022-09-28

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).

Conditions

  • Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children

Interventions

BIOLOGICAL

Botulinum toxin type A

Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-09-21
Completion
2018-09-04
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Israel
  • Mexico
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

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 NCT02106351 on ClinicalTrials.gov