Efficacy evaluation of oral baclofen treatment versus intrathecal baclofen in children with dystonic cerebral palsy - Oral/intrathecal therapy in children with dystonia
- Conditions
- Dystonic or spastic dystonic cerebral palsyMedDRA version: 9.1Level: SOCClassification code 10029205MedDRA version: 9.1Level: PTClassification code 10008129MedDRA version: 9.1Level: LLTClassification code 10021740
- Registration Number
- EUCTR2008-000833-23-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Severe dystonia in children with cerebral palsy
Patients responders to baclofen bolus test
Maximum age 16 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients for which there is a controindication for baclofen therapy
Children already treated with any anti-dystonic drugs at the time of the bolous test and children with previous surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the efficacy of treatment with baclofen for dystonia in children with dystonic or spastic-dystonic cerebral palsy<br><br>Compare the effect of intrathecal baclofen versus oral baclofen<br><br>Primary outcome measure Barry-Albright Dystonia Rating Scale (BAD);Secondary Objective: Health related quality of life<br><br>Secondary outcome measure: Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD);Primary end point(s): Three months after the treatment beginning where the BAD total score has to decrease of 2 or more points
- Secondary Outcome Measures
Name Time Method