Dystonic or spastic dystonic cerebral palsy MedDRA version: 9.1 Level: SOC Classification code 10029205 MedDRA version: 9.1 Level: PT Classification code 10008129 MedDRA version: 9.1 Level: LLT Classification code 10021740
Conditions
Interventions
Trade Name: LIORESAL*INTRATEC 1F 10MG 5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Baclofen
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of treatment with baclofen for dystonia in children with dystonic or spastic-dystonic cerebral palsy Compare the effect of intrathecal baclofen versus oral baclofen Primary outcome measure Barry-Albright Dystonia Rating Scale (BAD);Secondary Objective: Health related quality of life 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 | — |
Countries
Italy
Outcome results
None listed