Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT00367068
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT00367068
Study Brief:
Protocol Section:
NCT00367068