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Dysport® Pediatric Lower Limb Spasticity Study

NCT01249417 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2022-09-28

Study results available
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Summary

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Conditions

  • Cerebral Palsy
  • Muscle Spasticity
  • Children

Interventions

BIOLOGICAL

Botulinum toxin type A

I.M. (in the muscle) injection on day 1 of a single treatment cycle.

DRUG

Placebo

I.M. injection on day 1 of a single treatment cycle.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-02-28
Completion
2014-06-30

Countries

  • United States
  • Chile
  • France
  • Mexico
  • Poland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT01249417 on ClinicalTrials.gov