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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00221611
First received: September 12, 2005
Last updated: December 19, 2007
Last verified: December 2007

September 12, 2005
December 19, 2007
January 2000
Not Provided
Spasticity of patients after 4 years
Same as current
Complete list of historical versions of study NCT00221611 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Palsy
Drug: Administration of intrathecal baclofen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2006
Not Provided

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
Both
5 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00221611
1999/152
No
Not Provided
University Hospital, Ghent
Not Provided
Principal Investigator: Dr. Uyttendale, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP