Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)

changes in the number of epileptic seizures in patients

1\. To assess treatment efficacy with YCJ-01 by changes in the number of epileptic seizures in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex. 2. To assess the safety of the treatment with YCJ-01 in patients with refractory epilepsy secondary to Tuberous Sclerosis Complex. Variables de Evaluación Primaria Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period. Occurrence of Adverse Events (AE), Severe AE (SAE), AE resulting in study treatment withdrawal, AE of special interest (AESI), and changes in vital signs and laboratory values during the clinical trial.

To assess the response rate to YCJ-01/placebo

To evaluate the response rate to YCJ-01/placebo: responders will be defined as those patients who achieve at least a 50% reduction in the number of epileptic seizures compared with the baseline period (from visit P0 to P1). To evaluate the proportion of subjects treated with YCJ-01/placebo who achieve a 25%, 50%, 75%, or 90% reduction in the number of epileptic seizures compared with the baseline period (from visit P0 to P1). To evaluate the proportion of patients treated with YCJ-01/placebo who are seizure-free from the start of the assigned treatment. To evaluate the effect of YCJ-01 on seizure control (changes in seizure severity and types) before and after treatment initiation.