Dutch National ITB Study in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00367068
First received: August 21, 2006
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

The objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.


Condition Intervention Phase
Cerebral Palsy
Spasticity
Drug: baclofen, intrathecal
Device: infusion pump for intrathecal baclofen, Synchromed, Medtronic
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • For the double-blind, placebo-controlled dose-escalation test treatment phase:
  • original Ashworth Scale.
  • For the prospective, randomized, open-label implantation and follow-up phase:
  • PEDI, GMFM, original Ashworth Scale, Visual Analogue Scale (VAS) at 6 months.

Secondary Outcome Measures:
  • For the double-blind, placebo-controlled dose-escalation test treatment phase:
  • Visual Analogue Scale (VAS).
  • For the prospective, randomized, open-label implantation and follow-up phase:
  • CHQ-PF50 at 6 months.

Estimated Enrollment: 18
Study Start Date: January 2002
Study Completion Date: May 2007
Detailed Description:

Spasticity in cerebral palsy (CP) is a serious problem leading to pain, sleep disturbance, increased expenditure of energy and/or interference with positioning, transfers, dressing and body hygiene. In later stages, secondary phenomena, such as contractures, decubitus and heterotopic calcifications of joints or tendons may create large treatment problems. A substantial group of children with severe CP does not respond to regular treatments, such as physical therapy, orthopaedic surgery or oral medication. An effective treatment option for intractable spasticity is the continuous delivery of intrathecal baclofen (CITB). In 2000, the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a systematic review on the body of evidence about intrathecal baclofen (ITB) for spasticity in individuals with CP. It appeared that only a small and uncertain number of children had been studied. Except for two case-reports, none of the studies solely concerned children. The research methodology employed in three quarters of the available studies was not capable of confirming treatment effect. The AACPDM underlined the need for further high-level research in the form of prospective, randomized trials that use valid and reliable outcome measures in well described and homogeneous groups.

In 1998 the Dutch Study Group on Child Spasticity designed the Dutch national study on the effectiveness and safety of ITB for refractory spasticity in children with cerebral palsy. The Dutch national ITB study included four phases: 1] the selection phase, 2] the double-blind, placebo-controlled dose-escalation test treatment phase, 3] the prospective, randomized, open-label implantation phase and 4] the follow-up phase.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 4 and 16 years
  • spastic diplegia or tetraplegia as part of CP
  • insufficient response to oral spasticity-reducing medication
  • in a mixed CP syndrome, spasticity has to be the most prominent sign
  • spasticity results in a decrease in the quality of life of the child and/or its caregivers
  • sufficient motivation for participation in the study including availability for follow-up
  • magnetic resonance imaging of the brain rules out progressive causes of spasticity

Exclusion Criteria:

  • hypersensitivity to baclofen
  • contraindications for general anaesthesia
  • insufficient general health
  • intractable epileptic seizures
  • infection of the lumbar skin
  • a systemic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367068

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, NL 6202 AZ
Sponsors and Collaborators
Maastricht University
Medtronic
Investigators
Study Chair: Johan SH Vles, MD, PhD, Prof Maastricht University Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00367068     History of Changes
Other Study ID Numbers: PF-147
Study First Received: August 21, 2006
Last Updated: November 15, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Cerebral palsy
Spasticity
Child
Baclofen
Intrathecal injection

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations

ClinicalTrials.gov processed this record on September 18, 2014