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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221611
First Posted: September 22, 2005
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00221611     History of Changes
Other Study ID Numbers: 1999/152
First Submitted: September 12, 2005
First Posted: September 22, 2005
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases