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Dysport® Pediatric Lower Limb Spasticity Follow-on Study

NCT01251380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-09-28

Study results available
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Summary

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

Conditions

  • Cerebral Palsy
  • Muscle Spasticity
  • Children

Interventions

BIOLOGICAL

Botulinum toxin type A

Intramuscular (IM) injection on day 1 of each treatment cycle.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

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
2011-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Chile
  • France
  • Mexico
  • Poland
  • 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 NCT01251380 on ClinicalTrials.gov