Clinical study on efficacy and safety of sirolimus against epileptic seizures of focal cortical dysplasia type II
- Conditions
- Patients with epilepsy with focal cortical dysplasia type 2
- Registration Number
- JPRN-UMIN000030962
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 2
Not provided
1) Patients taking oral administration of other test drugs (drugs used in other clinical studies / clinical trials) before the start of the study, just before the observation period. 2) Currently, patients taking sirolimus or everolimus internally or who have ever taken internal medicine. 3) Felbamate, Vigabatrin was taking within 6 months. 4) Patients who can not accurately record the number and time of epileptic seizures by the patient or substitute. 5) Patients who are suspected of progressive lesions with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) performed so far. 6) Patients who underwent cerebral surgery for epilepsy (cortical resection, functional hemisphere dissection, cerebral ablation, vagus nerve stimulation) within 180 days prior to obtaining consent. 7) Patients during ketogenic diet therapy. 8) Patients who have suicide attempts in the past. 9) Patients with a history or complication of substance abuse (including alcohol abuse). 10) Patients who are pregnant women who can not perform contraception during the study period (including partners), pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety in clinical research enforcement and presence or absence of occurrence of adverse events
- Secondary Outcome Measures
Name Time Method Percentage reduction in the incidence of epileptic seizures per week during fixed administration period, variable administration period (dose control period) of sirolimus, compared with the previous observation period without administration