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

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ClinicalTrials.gov Identifier: NCT00221611
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
University Hospital, Ghent

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Administration of intrathecal baclofen Phase 2

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
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
Study Start Date : January 2000
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources




Primary Outcome Measures :
  1. Spasticity of patients after 4 years


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

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00221611     History of Changes
Other Study ID Numbers: 1999/152
First Posted: September 22, 2005    Key Record Dates
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