Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Information source: University Hospital, Ghent
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Palsy
Intervention: Administration of intrathecal baclofen (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Dr. Uyttendale, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Summary
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral
palsy patients, by means of standardized and internationally accepted scales
Clinical Details
Official title: Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Spasticity of patients after 4 years
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
Minimum age: 5 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital Ghent, Ghent 9000, Belgium
Additional Information
Website University Hospital Ghent
Starting date: January 2000
Ending date: August 2006
Last updated: December 19, 2007
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