Tests a cannabis extract for hard-to-control seizures in tuberous sclerosis
Tests a cannabis extract against placebo in people with tuberous sclerosis and hard-to-control seizures.
Plain-language title generated from the registry record
Registry title: Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
Key facts
- Where
- Barcelona and Madrid, SpainSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 65 years old?
Source: NCT07403266, who can take part
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Ruber InternacionalMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oils4Cure
- Trial code
- NCT07403266EU 2024-520171-27-00
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
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.
Inclusion: Refractory epilepsy secondary to TSC, defined as that not responding successfully to traditional AEDs (2 or more), ketogenic diet, vagal nerve stimulator, and/or whose patients are not candidate for epilepsy surgery or persist with seizures after surgery; Patients with a minimum of 4 epileptic seizures or more within 4 weeks prior to the initiation of the assigned treatment in the trial, with observable external signs (loss of consciousness or motor component); Stability in AEDs doses, and in ketogenic diet/programming of the device associated with the vagal nerve stimulator with no changes for at least 4 weeks prior to the initiation of the assigned treatment; Patients who are in treatment with 3 or less AEDs at the time of signing the informed consent. For the purposes of assessing eligibility, Clobazam will not be counted as AED Willingness by patients or caregivers/family members (in case of patients who are minors or under legal guardianship) to complete the seizure diary; In case of women of child-bearing age, for safety, those who agree to follow the required contraceptive measures from the signing of the informed consent until three months after stop the intake of the investigational medicinal product; Patients who have signed the informed consent either by themselves or through a legal representative; -.
Exclusion: Pregnancy. Breastfeeding women To have participated in another clinical trial, unless at least 5 half- lives of the investigational product have elapsed, or 12 weeks, if it is a product with cannabis oil; Patients who have received products with cannabis oil in the last 12 weeks. Patients who did not correctly follow the AED treatment in the 4 weeks prior to the intervention assigned in the trial; Patients who changed medication or AED dose, ketogenic diet, or the vagal stimulator during the 4 weeks prior to the initiation of the intervention assigned in the trial; Allergy to any of the components of the investigational medicinal product/placebo; Family (considering only first-degree blood relatives) or personal history of schizophrenia; Personal history of suicide attempts; 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; Patients or family/caregivers (in case of patients who are minors or under legal guardianship) who does not agree to comply with the requirements and trial visits or present a high risk of non-compliance with the protocol, according to the treating physician; -.