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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00221611

Enrollment

Registered

2005-09-22

Start date

2000-01-31

Completion date

2006-08-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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

Interventions

DRUGAdministration of intrathecal baclofen

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame
Spasticity of patients after 4 years	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026