Overview

This trial is active, not recruiting.

Conditions cerebral palsy, muscle spasticity, children
Treatments botulinum type a toxin (dysport®), placebo
Phase phase 3
Sponsor Ipsen
Start date July 2011
End date July 2014
Trial size 241 participants
Trial identifier NCT01249417, Y-55-52120-141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
botulinum type a toxin (dysport®)
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
(Experimental)
15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
botulinum type a toxin (dysport®)
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
(Placebo Comparator)
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
placebo
I.M. injection on day 1 of a single treatment cycle.

Primary Outcomes

Measure
Intensity of muscle tone rated by the Modified Ashworth scale
time frame: Change from baseline at week 4

Secondary Outcomes

Measure
Physician's global assessment (PGA) of the treatment response.
time frame: Week 4
Measurement of progress towards individual therapy
time frame: Week 4

Eligibility Criteria

Male or female participants from 2 years up to 17 years old.

Inclusion Criteria: - Children aged 2 to 17 years with cerebral palsy - Equinus foot position - Ambulatory - Intensity of muscle tone greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale Exclusion Criteria: - Fixed contracture - Previous phenol, alcohol injection or surgical intervention - Other neurological / neuromuscular disorder - Severe athetoid or dystonic movements

Additional Information

Official title A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Ipsen.