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

This study has been completed.

First Received: September 12, 2005 Last Updated: December 19, 2007 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00221611

Purpose

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

Condition	Intervention	Phase
Cerebral Palsy	Drug: Administration of intrathecal baclofen	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Spasticity of patients after 4 years

Estimated Enrollment:	80
Study Start Date:	January 2000
Study Completion Date:	August 2006

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

Ages Eligible for Study:	5 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221611

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Dr. Uyttendale, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	1999/152
Study First Received:	September 12, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00221611 History of Changes
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Brain Damage, Chronic
Nervous System Diseases
Baclofen
Physiological Effects of Drugs
Central Nervous System Diseases
Neuromuscular Agents
Brain Diseases

Pharmacologic Actions
Cerebral Palsy
GABA Agonists
Muscle Relaxants, Central
Therapeutic Uses
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010