Dutch National ITB Study in Children With Cerebral Palsy

Status Completed

Clinical Trial 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 Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00367068
Study type	Interventional
Source	Maastricht University Medical Center
Contact
Status	Completed
Phase	Phase 3
Start date	January 2002
Completion date	May 2007

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.