Baclofen, intrathecal and infusion pump for intrathecal baclofen, Synchromed, Medtronic in Cerebral Palsy and Spasticity - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Maastricht, Netherlands, NL 6202 AZ
    - University Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

Medtronic

Investigators

Study Chair: Johan SH Vles, MD, PhD, Prof, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1017/s0012162200001183. No abstract available.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria