Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity

Phase 2

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT00221611
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Detailed Description

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-22
• Study Completion: 2006-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• CP patients with therapy-resistent spasticity
• Patients with sufficient body weight in relation to the volume
• Oral medication has failed: insufficient effect or too many side-effects
• The patient and family understand the objectives of the treatment and accept those objectives
• Informed Consent

Exclusion Criteria

• Contra-indications for surgery (e.g. infection)
• Hypersensitivity to oral Baclofen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Spasticity of patients after 4 years

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium