Spectrum (EudraCT: 2022-000490-13; Code EstuEla2022) is a multicenter, double-blind, placebo-controlled clinical trial of a novel therapy to be administered in association with pre-existing treatments. The trial has been designed to verify the efficacy and safety of YCJ-01, a full spectrum cannabis extract, when treating refractory epilepsy associated with Tuberous Sclerosis Complex (TSC).
TSC is a rare multi-system genetic disease that causes the development of benign tumors in the brain, as well as in other vital organs. This condition is commonly seen to affect the central nervous system and consequently, epileptic seizures are a symptom often associated with TSC, seizures that can be particularly difficult to control.
Indeed, epilepsy is a very common problem in patients with TSC and it commences in their first years of life. Although there are some therapeutic options for these patients, as many as 63.3% of them do not respond to these and their epilepsy remains uncontrolled, with the majority suffering from seizures on a daily basis. Significantly, poor control of their seizures has important consequences and it is correlated with intellectual disability and autism spectrum disorder.
Given the lack of effective treatments for the management of refractory epilepsy in association with TSC, a prospective, experimental clinical trial is being carried out – SPECTRUM.
SPECTRUM will enroll 84 patients of both sexes, aged between 2 and 65 years old, all of whom suffer epilepsy associated with TSC that is refractory to currently available therapies.
The study will be carried out in two parts:
Part 1
Patients will be randomized to the YCJ-01 or placebo group 1:1, and the treatments will be administered for two months as adjuvant therapy for TSC-associated seizures in children or adults.
Part 2
Open-label extension during which all the patients enrolled on the study will receive active treatment with YCJ-01 for four months to evaluate its long-term efficacy and safety.
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