Actively Recruiting
Treatment With Full-spectrum Cannabis Extract for Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
Led by Oils4Cure · Updated on 2026-02-11
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the use of YCJ-01, a full-spectrum cannabis extract, to treat refractory epilepsy caused by Tuberous Sclerosis Complex (TSC), a condition often starting early in life that causes frequent seizures unresponsive to many current therapies. The study aims to assess changes in seizure frequency and the safety of YCJ-01 compared to placebo. Poor seizure control in TSC patients is linked to intellectual and developmental challenges, highlighting the need for new treatment options. Participants will be randomly assigned to receive either YCJ-01 or a placebo in a triple-blind setup. The treatment effects are measured by comparing the number of monthly seizures during the treatment period to a baseline period. The study observes seizure reduction at various points including the second month and after reaching the final dose. It also evaluates the proportion of patients achieving significant seizure reductions or becoming seizure-free. Throughout the study, participants will record seizures in a diary, and researchers will monitor adverse events, vital signs, and lab tests to assess safety. Seizure severity and types will be tracked over multiple visits. The primary outcome is seizure frequency change over six months, with secondary outcomes including response rates and seizure control. The trial lasts at least six months, with ongoing evaluation for both treatment and safety.
CONDITIONS
Brief 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 old
- Diagnosis of Tuberous Sclerosis Complex confirmed by clinical criteria or genetic study
- Refractory epilepsy secondary to TSC not responding to at least two antiepileptic drugs, ketogenic diet, vagal nerve stimulation, or surgery
- At least 4 epileptic seizures with observable external signs in the 4 weeks before treatment start
- Stable doses of antiepileptic drugs, ketogenic diet, and vagal nerve stimulator programming for at least 4 weeks before treatment
- Using 3 or fewer antiepileptic drugs at consent signature (Clobazam not counted)
- Willingness of patients or caregivers to complete seizure diary
- Women of child-bearing age agree to use contraceptive measures during and 3 months after treatment
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Receiving corticosteroid treatment at consent
- Pregnant or breastfeeding women
- Participation in another clinical trial within specified washout periods
- Use of cannabis oil products in the last 12 weeks
- Poor adherence to antiepileptic drugs in the 4 weeks before treatment
- Medication changes in the 4 weeks before treatment including drugs, ketogenic diet, or vagal nerve stimulator
- Cardiac, renal, hepatic failure, pancreatic insufficiency, or blood disorders beyond normal limits
- Uncontrolled severe medical conditions including liver disease, infections, or diabetes
- Patients or caregivers unwilling to comply with trial visits or protocol
- Allergy to investigational product or placebo components
- Family history of schizophrenia in first-degree relatives
- Personal history of suicide attempts
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either the full-spectrum cannabis extract YCJ-01 or placebo to manage refractory epilepsy associated with tuberous sclerosis complex. The treatment aims to reduce the number and severity of epileptic seizures.
Multiple visits including baseline and periodic follow-up visits during treatment
Duration - Up to 3 months after treatment
Participants are monitored after treatment to assess seizure control, adverse events, and sustained response to the intervention.
Periodic visits for safety and response assessment
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
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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