Status:
COMPLETED
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Lead Sponsor:
University Hospital, Ghent
Conditions:
Cerebral Palsy
Eligibility:
All Genders
5-25 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- Contra-indications for surgery (e.g. infection)
- Hypersensitivity to oral Baclofen
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00221611
Start Date
January 1 2000
End Date
August 1 2006
Last Update
December 28 2007
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000