RecruitingPhase 3NCT07403266

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


Sponsor

Oils4Cure

Enrollment

84 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a full-spectrum cannabis extract for people with tuberous sclerosis complex (TSC) — a genetic condition that causes non-cancerous tumors to grow throughout the body, often leading to severe, drug-resistant epilepsy (seizures that don't respond to medication). **You may be eligible if...** - You are between 2 and 65 years old - You have a confirmed diagnosis of TSC - You have epilepsy that has not responded to at least 2 different anti-seizure medications, ketogenic diet, vagal nerve stimulator, or surgery - You have had at least 4 seizures with visible symptoms in the 4 weeks before the study starts - Your current seizure medications and other treatments have been stable for at least 4 weeks **You may NOT be eligible if...** - You have a history of severe psychiatric disorders like psychosis - Your seizures are well controlled with current treatments - You have significant liver or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYCJ-01 Full Spectrum cannbis Extract

Ful Spectrum cannabis extract

DRUGPlacebo

Placebo


Locations(1)

Hospital Ruber Internacional

Madrid, Spain

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NCT07403266


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