Status:
COMPLETED
Dutch National ITB Study in Children With Cerebral Palsy
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Medtronic
Conditions:
Cerebral Palsy
Spasticity
Eligibility:
All Genders
4-16 years
Phase:
PHASE3
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 and/or interference with positioning, transfers, dressing and body hygiene. I...
Eligibility Criteria
Inclusion
- 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
- hypersensitivity to baclofen
- contraindications for general anaesthesia
- insufficient general health
- intractable epileptic seizures
- infection of the lumbar skin
- a systemic infection
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00367068
Start Date
January 1 2002
End Date
May 1 2007
Last Update
November 19 2007
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands, NL 6202 AZ