Clinical trial

A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT® Used In The Treatment Of Upper Limb Spasticity In Children

Name

Y-52-52120-153

Description

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).

Trial arms

Trial start

2014-04-01

Estimated PCD

2017-09-21

Trial end

2018-09-04

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Group A, Group B, Group C

Other names:

AbobotulinumtoxinA (Dysport®)

Size

212

Primary endpoint

Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG

Baseline (TC 1, Day 1) and TC 1, Week 6.

Eligibility criteria

Inclusion Criteria: * Upper limb spasticity due to cerebral palsy * Body weight 10 kg or over * MAS score of 2 or more in affected elbow or wrist flexors Exclusion Criteria: * Fixed myocontracture * Previous phenol or alcohol injection within 1 year * Severe athetoid or dystonic movements * Previous or planned surgery for spasticity in elbow or wrist flexors * Neuromuscular disorders * Previous Rhizotomy within 6 months * Intrathecal baclofen within 30 days

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 212, 'type': 'ACTUAL'}}

Updated at

2022-09-28

1 organization

1 product

1 indication

Organization

Ipsen

Product

Botulinum toxin type A

Indication

Upper Limb Spasticity in Children (Altered Skeletal Muscle Performance)