OncoMatch/Clinical Trials/NCT07403266
Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
Is NCT07403266 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies YCJ-01 Full Spectrum cannbis Extract for tuberous sclerosis complex (tsc).
Treatment: YCJ-01 Full Spectrum cannbis Extract — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: antiepileptic drug
not responding successfully to traditional AEDs (2 or more)
Must have received: ketogenic diet
not responding successfully to...ketogenic diet
Must have received: vagal nerve stimulator
not responding successfully to...vagal nerve stimulator
Cannot have received: cannabis oil
Patients who have received products with cannabis oil in the last 12 weeks
Lab requirements
Blood counts
platelets < 80000/mm3, white blood cell count <3000/mm3, hematologic dysfunction with values above the normal limits
Kidney function
values above the normal limits of creatinine and urea
Liver function
values 2 times the normal limits of transaminases, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C)
Cardiac function
cardiac failure
Cardiac, renal, and hepatic failure, pancreatic insufficiency, or hematologic dysfunction with values above the normal limits of creatinine and urea; values 2 times the normal limits of transaminases, lipases, and serum amylase; platelets < 80000/mm3, and white blood cell count <3000/mm3. Uncontrolled severe medical condition such as: hepatic disease, increased bilirubin levels more than twice the normal limit, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as blood glucose >150 mg%), (chronic or acute) active infections or uncontrolled severe infections, or active bleeding.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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