Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial) - RATE
- Conditions
- Epilepsy in children with Tuberous Sclerosis Complex
- Registration Number
- EUCTR2010-022655-29-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Children with definite TSC older than 3 months, up to 12 yrs old, with catastrophic epilepsy (West syndrome or intractable epilepsy defined as 1 or more seizures/week despite two adequate trials of anti-epileptic drug regimens).
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
Renal dysfunction, surgery during 6wk before inclusion, current infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of rapamycin (Sirolimus) on intractable epilepsy in children with Tuberous Sclerosis Complex.;Secondary Objective: To evaluate tolerability of rapamycin (Sirolimus) in children with TSC.;Primary end point(s): Seizure frequency during the last month of treatment versus baseline (percentage change).
- Secondary Outcome Measures
Name Time Method