Clinical Research Directory

Inclusion Criteria: * Male or female aged from 4 up to 16 weeks (44-56 weeks of gestational age) at the day of randomization * Parents/caregivers are willing to and able to give informed consent form for the participation in the study * Parents/caregivers are willing to and able to comply with all study requirements * Definite diagnosis of TSC according to the Consensus criteria (Northrup,2013) * At least 1 focus of cortical dysplasia disclosed on brain MRI Exclusion Criteria: * history of seizures prior to randomization, * history of antiepileptic treatment, * history of treatment with mTOR (mammalian Target of Rapamycin) inhibitor, * gestational age below 44 weeks at the day of randomization, * body weight lower than 3 kg at the day of randomization, * SEGA (Subependymal Giant Cell Astrocytoma) or other TSC-associated lesion requiring urgent surgical intervention * recent surgery within 1 month prior to the randomization * intercurrent infection at the date of randomization * known history of HIV seropositivity * live vaccination within 1 month prior to randomization\* * lack of first TBC and hepatitis B vaccinations * Any significant clinical, laboratory , ECG or other abnormalities, comorbidity or concomitant treatment which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study. * Use of an investigational drug within 1 month prior to randomization.