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NCT00221611 Clinical Trial

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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00221611
Other study ID # 1999/152
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated December 19, 2007
Start date January 2000
Est. completion date August 2006

Study information
Verified date December 2007
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 25 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Administration of intrathecal baclofen

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spasticity of patients after 4 years
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