Treatment of gait problems caused by spastic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.

Phase 1

• Conditions: Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy.; MedDRA version: 18.0Level: LLTClassification code 10015112Term: Equinus deformity of foot, acquiredSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004474-42-DK
• Lead Sponsor: Copenhagen University Hospital at Hvidovre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

- Spastic cerebral palsy diagnosed by a neuro-pediatrician
- Spasticity/increased tone in m. triceps surae
- 3-8 years of age
- GMFCS level I or II

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
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

Lacking ability to cooperate and take part in three-dimensional gait analysis
- More than five previous BoNT-A treatments or insufficient effect of the latest treatment
- Hypersensitivity caused by BoNT-A or one or more of the ancillary substances
- Infection at the intended injection site
- Injection treatment with BoNT-A within the previous four months
- Operations in the lower extremities within the previous year
- Planned operations in the lower extremities, that is deemed to interfere with research outcome parametres during the project period

Study & Design

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