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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00221611     History of Changes
Other Study ID Numbers: 1999/152
Study First Received: September 12, 2005
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
 Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013