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

Phase 1

• Conditions: ower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.; MedDRA version: 12.1Level: LLTClassification code 10024132Term: Leg spasticity

• Registration Number: EUCTR2009-017709-12-FR
• Lead Sponsor: Ipsen Pharma SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Subjects must satisfy all of the following inclusion criteria to be eligible for the
study:
(1) Signed informed consent obtained from the child’s parent(s)/guardian(s) and a signed assent from the child when and where applicable.
(2) Be from 2 to 17 years of age, inclusive.
(3) Have a diagnosis of CP as defined by Rosenbloom.
(4) Be ambulatory with spastic hemiparesis, paraparesis, diparesis or tetraparesis characterised by an equinus foot positioning during the stance phase of the gait.
(5) Have ability to walk (sufficient to complete video 2D motion analysis) with or without walking aids.
(6) Have a MAS score =2 at the ankle joint of the (most) affected lower limb
to be injected.
(7) Have a spasticity grade (Y) between 2 and 4, inclusive on the TS assessed at the ankle joint of the most affected limb to be injected with a spasticity angle (X) of 10o or more.
(8) Be classified as GMFCS Level 1 to 3, inclusive.
(9) Botulinum toxin naïve subjects or subjects having received their last BTX treatment of any type more than six months prior to study entry for any condition.
(10) If undergoing pre-study physiotherapy, it must have begun at least one month prior to study start and be continued during the study at the same pre-study frequency and intensity (as well as maintaining the usual level of physical activity until the end of the study) up to at least the Week 12 visit.
(11) Be instructed and willing to use their casting/ orthoses in the same way as before entry into the study until the end of the Week 12 visit.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are to be excluded if any of the following applies:
(1) Diagnosed as resistant to BTX treatment of any type.
(2) Evidence of non-ambulatory status.
(3) Fixed myocontracture defined by a passive range of motion (Xv1) of 10°
or less in ankle dorsiflexion.
(4) Subjects likely to be treated with BTX in the upper limbs during the course
of this double blind study.
(5) Severe athetoid or dystonic movements in the targeted lower limb(s).
(6) Significant difference (>2 cm) between the length of legs, defined
clinically and confirmed, as required, by scanogram.
(7) Current need for surgery or previous surgery for spasticity of the lower
limb muscles.
(8) Serial casting in the past 12 weeks.
(9) Previous injection of alcohol and/or phenol into the lower limb(s).
(10) Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study treatment.
(11) Be pregnant and/or lactating.
(12) Female subjects, not willing to use contraceptive measures throughout the course of the study if post-pubertal and sexually active.
(13) Inability or unwillingness to comply with the protocol.
(14) Subjects with any clinical (or sub-clinical) evidence of marked defective neuromuscular transmission (e.g. Lambert-Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders.
(15) Known sensitivity to BTX or to any of the components in the formulation.
(16) An infection at the injection site(s).
(17) Ongoing treatment with intrathecal baclofen or previous/planned rhizotomy.
(18) Treatment with a new investigational drug within 30 days prior to enrolment into the study or are scheduled to receive such a drug during the study period.
(19) Any medical condition, laboratory or diagnostic procedure finding, which might compromise compliance with the objectives and procedures of this protocol or preclude administration of BTX-A, as judged by the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified