Treatment With Full-spectrum Cannabis Extract of Refractory Epilepsy Associated With Tuberous Sclerosis Complex (TSC)
NCT07403266 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2026-02-11
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)
Interventions
- DRUG
-
YCJ-01 Full Spectrum cannbis Extract
Ful Spectrum cannabis extract
- DRUG
-
Placebo
Sponsors & Collaborators
-
Oils4Cure
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 2 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2026-06-01
- Completion
- 2027-06-30
Countries
- Spain
Study Locations
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