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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Drug: Administration of intrathecal baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00221611

1999/152

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)