Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367068
Status:
COMPLETED
Last Update Posted:
2007-11-19
First Post:
2006-08-21
Brief Title:
Dutch National ITB Study in Children With Cerebral Palsy
Sponsor:
Maastricht University
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Intrathecal Baclofen Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Spasticity in cerebral palsy CP is a serious problem leading to pain sleep disturbance increased expenditure of energy andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None