Back to resultsIntrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Administration of intrathecal baclofen
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
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 Exclusion Criteria: Contra-indications for surgery (e.g. infection) Hypersensitivity to oral Baclofen
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Spasticity of patients after 4 years
Secondary Outcome Measures
Full Information
NCT ID
NCT00221611
First Posted
September 12, 2005
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00221611
Brief Title
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Official Title
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Administration of intrathecal baclofen
Primary Outcome Measure Information:
Title
Spasticity of patients after 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Exclusion Criteria:
Contra-indications for surgery (e.g. infection)
Hypersensitivity to oral Baclofen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Uyttendale, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
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