Actively Recruiting
Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
Led by Oils4Cure · Updated on 2026-02-11
84
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any sex between 2 and 65 years of age (both included)
- Confirmed diagnosis of Tuberous Sclerosis Complex by clinical criteria and/or genetic study
- Refractory epilepsy secondary to TSC, not responding to two or more traditional antiepileptic drugs, ketogenic diet, vagal nerve stimulator, or surgery
- At least 4 epileptic seizures with observable signs within 4 weeks before treatment start
- Stable doses of antiepileptic drugs, ketogenic diet, or vagal nerve stimulator for at least 4 weeks before treatment start
- Currently taking 3 or fewer antiepileptic drugs (Clobazam not counted)
- Willingness to complete seizure diary by patient or caregiver
- Women of childbearing age agree to use contraception from consent until 3 months after stopping treatment
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Receiving corticosteroid treatment at time of consent
- Pregnant or breastfeeding women
- Participation in another clinical trial within 5 half-lives or 12 weeks if cannabis oil was used
- Received cannabis oil products in last 12 weeks
- Poor adherence to antiepileptic drug treatment in 4 weeks before trial
- Changes in medication, ketogenic diet, or vagal nerve stimulator in 4 weeks before trial
- Cardiac, renal, hepatic failure, pancreatic insufficiency, or hematologic dysfunction beyond specified lab limits
- Uncontrolled severe medical conditions including liver disease, cirrhosis, hepatitis B or C, uncontrolled diabetes, active infections, or bleeding
- Patient or caregiver unwilling or at high risk of non-compliance
- Allergy to components of investigational product or placebo
- Personal or first-degree family history of schizophrenia
- Personal history of suicide attempts
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Ruber Internacional
Madrid, Spain, 28034
Actively Recruiting
Research Team
G
Gil Nagel, Antonio Gil Nagel, Antonio, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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