Full-spectrum cannabis extract for hard-to-treat seizures in tuberous sclerosis

Plain-English translation of NCT07403266 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing YCJ-01, a full-spectrum cannabis extract, to see if it can help reduce seizures in people with tuberous sclerosis complex (TSC) whose seizures have not been controlled by other treatments. About 84 people will take part, with some receiving the medication and others receiving a placebo (inactive treatment), so researchers can compare how well it works. The main goal is to see whether this medication reduces the number of seizures people experience each month.

Most people with TSC-related epilepsy continue to have daily seizures even after trying multiple standard seizure medications, vagus nerve stimulation, diet changes, or surgery. Because current options don't work well enough for many patients, researchers are testing whether this medication might offer a new way to control seizures and improve quality of life.

Do you qualify?

You likely qualify if…

you are between 2 and 65 years old
you have been diagnosed with tuberous sclerosis complex confirmed by a doctor or genetic test
you have refractory epilepsy (seizures that haven't responded to at least 2 seizure medications and other treatments like diet or surgery)
you've had at least 4 seizures with visible signs (like loss of consciousness or muscle movements) in the 4 weeks before starting the trial
your current seizure medications and other treatments have been stable with no changes for at least 4 weeks
you or your caregiver agrees to keep a daily seizure diary

You likely don't qualify if…

you are currently taking corticosteroid medications
you are pregnant or breastfeeding
you have taken any cannabis oil products in the last 12 weeks
you have significant heart, kidney, liver, or blood disorders, or abnormal blood test results
you have serious uncontrolled infections, active bleeding, or uncontrolled diabetes

What participation looks like

You will be randomly assigned to receive either the medication or a placebo and will take it as directed while continuing your current seizure medications. You'll need to keep a daily diary of your seizures and attend study visits where doctors will check your health, review your seizure diary, and do blood tests to monitor for any side effects. The study will track how many seizures you have during treatment and compare it to how many you had before starting.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(1 site)

Spain

Hospital Ruber Internacional, Madrid