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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Baclofen's effect on spasticity in cerebral palsy patients receiving intrathecal administration?
How does intrathecal Baclofen compare to oral antispasmodics in managing therapy-resistant spasticity in cerebral palsy?
Are there specific biomarkers that predict response to intrathecal Baclofen in cerebral palsy patients with spastic diplegia?
What are the long-term adverse events associated with intrathecal Baclofen pumps in cerebral palsy populations?
What combination therapies with intrathecal Baclofen show promise for cerebral palsy spasticity beyond NCT00221611 findings?
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium
University Hospital Ghent🇧🇪Ghent, Belgium