Dutch National ITB Study in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367068
• Other study ID #: PF-147
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2006
• Last updated: November 15, 2007
• Start date: January 2002
• Est. completion date: May 2007

Study information

• Verified date: November 2007
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity

Intervention

Drug:
• baclofen, intrathecal

Device:
• infusion pump for intrathecal baclofen, Synchromed, Medtronic

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	Medtronic

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For the double-blind, placebo-controlled dose-escalation test treatment phase:
Primary	original Ashworth Scale.
Primary	For the prospective, randomized, open-label implantation and follow-up phase:
Primary	PEDI, GMFM, original Ashworth Scale, Visual Analogue Scale (VAS) at 6 months.
Secondary	For the double-blind, placebo-controlled dose-escalation test treatment phase:
Secondary	Visual Analogue Scale (VAS).
Secondary	For the prospective, randomized, open-label implantation and follow-up phase:
Secondary	CHQ-PF50 at 6 months.