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

NCT ID: NCT00221611

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2006-08-31

Brief Summary

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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

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

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of intrathecal baclofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Principal Investigators

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Dr. Uyttendale, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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1999/152

Identifier Type: -

Identifier Source: org_study_id