Dutch National ITB Study in Children With Cerebral Palsy
Information source: Maastricht University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Palsy; Spasticity
Intervention: baclofen, intrathecal (Drug); infusion pump for intrathecal baclofen, Synchromed, Medtronic (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Maastricht University Official(s) and/or principal investigator(s):
Johan SH Vles, MD, PhD, Prof, Study Chair, Affiliation: Maastricht University
Summary
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.
Clinical Details
Official title: Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
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
Minimum age: 4 Years.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospital Maastricht, Maastricht NL 6202 AZ, Netherlands
Additional Information
Related publications: Butler C, Campbell S. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy. AACPDM Treatment Outcomes Committee Review Panel. Dev Med Child Neurol. 2000 Sep;42(9):634-45. Review. No abstract available.
Starting date: January 2002
Ending date: May 2007
Last updated: November 15, 2007
|
