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

NCT07403266 | Recruiting Phase 3 DMC

• 2 other identifiers: EstuEla20222024-520171-27-00
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberous Sclerosis Complex (TSC)

Keywords

Refractary Epilepsy

Outcome Measures

Primary Outcomes (1)

• changes in the number of epileptic seizures in patients

  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. Variables de Evaluación Primaria Comparison of the number of monthly seizures since the initiation of the treatment with YCJ-01 with respect to the baseline period: in patients assigned to receive YCJ-01, change in the number of monthly seizures in the second month of treatment with respect to the baseline period; and in patient assigned to receive a placebo, changes in the number of monthly seizures in the second month of treatment with YCJ-01 with respect to the baseline period. Occurrence of Adverse Events (AE), Severe AE (SAE), AE resulting in study treatment withdrawal, AE of special interest (AESI), and changes in vital signs and laboratory values during the clinical trial.

  6 months

Secondary Outcomes (1)

• To assess the response rate to YCJ-01/placebo

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

Randomized patients assigned to the active treatment group.

Drug: YCJ-01 Full Spectrum cannbis Extract

placebo

PLACEBO COMPARATOR

Randomized patients assigned to the placebo group.

Drug: YCJ-01 Full Spectrum cannbis Extract; Drug: Placebo

Interventions

YCJ-01 Full Spectrum cannbis Extract DRUG

Ful Spectrum cannabis extract

Experimental; placebo

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Oils4Cure: lead

Study Sites (1)

Hospital Ruber Internacional

Madrid, 28034, Spain

RECRUITING

Related Links

• registro español de ensayos clínicos

MeSH Terms

Conditions

Tuberous Sclerosis

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Central Study Contacts

Gil Nagel, Antonio Gil Nagel, Antonio, Doctor

CONTACT

+34 913875000; ensayosepi@neurologiaclinica.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind clinical trial with two treatment arms, randomized 1:1, placebo-controlled (part 1), followed by an open-label phase with a single treatment arm using the investigational product (part 2).

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)