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

University Hospital, Ghent1 site in 1 country80 target enrollmentJanuary 2000

ConditionsCerebral Palsy

DrugsAdministration of intrathecal baclofen

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cerebral Palsy
Sponsor: University Hospital, Ghent
Enrollment: 80
Locations: 1
Primary Endpoint: Spasticity of patients after 4 years
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2000

End Date

August 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Eligibility 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