A PHASE III, PROSPECTIVE, MULTICENTRE, OPEN LABEL, EXTENSION STUDY ASSESSING THE LONG TERM SAFETY AND EFFICACY OF REPEATED TREATMENT WITH 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: EUCTR2010-019102-17-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: 221

Inclusion Criteria

All subjects must fulfil the following inclusion criteria to be eligible for the study:
(1) Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.
(2) Without any major protocol deviations and/or any ongoing AEs, either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.
(3) Written informed consent obtained from the child’s parent(s)/guardian(s) for this study, and assent from the child, when and where applicable.
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 apply:
(1) Fixed myocontracture as defined by a passive range of motion (Xv1) of 10° or less in ankle dorsiflexion.
(2) Unwillingness or inability to comply with the protocol.
(3) Current need for surgery of the muscles of any affected limb.
(4) 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 medication or a planned treatment with such drugs.
(5) Be pregnant and/or lactating.
(6) Not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.
(7) An infection at the injection site(s).
(8) Planned treatment with any new investigational drug or device during the
study period.

Study & Design

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