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

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

Completed

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of intrathecal baclofen

Drug

Primary outcomes

Spasticity of patients after 4 years

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start: 2000
Study completion: 2006
First posted: Sep 22, 2005
Registry last updated: Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed