Cannabidiol for Lennox Gastaut Syndrome

(EpiGOAL Trial)

This trial aims to evaluate the effectiveness of a Cannabidiol Oral Solution (CBD-OS) as an additional treatment for adults with Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy characterized by frequent seizures. Participants will take the CBD-OS for 24 weeks to determine its impact on reducing seizure activity. It suits individuals with LGS who are currently experiencing seizures and have not used this specific CBD treatment in the past three months. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and proven effective treatment can benefit more patients.

You can continue taking your current seizure medications as long as they have been stable for at least 4 weeks before the study. However, if you are using strong inducers of certain enzymes with CBD-OS, you may need to adjust the dosage.

Research has shown that Cannabidiol Oral Solution (CBD-OS) is generally safe for individuals with Lennox-Gastaut syndrome (LGS). In one study, most participants experienced side effects, but these were usually mild or moderate. Common side effects included fatigue, diarrhea, and reduced appetite.

Another study found that CBD-OS remained safe even with long-term use. The side effects remained consistent with those in shorter studies, indicating they did not worsen over time.

Unlike the standard treatments for Lennox Gastaut Syndrome, which often include anti-seizure medications like valproate or lamotrigine, Cannabidiol Oral Solution (CBD-OS) offers a unique approach. Derived from cannabis, CBD-OS is notable for its potential to manage seizures without the psychoactive effects associated with THC, another cannabis component. Researchers are excited about its ability to be titrated up to a specific dose, tailored to each patient's tolerance, potentially offering a more personalized treatment experience. Additionally, the use of a natural compound as an active ingredient represents a novel mechanism of action, providing hope for those who haven't responded well to traditional anti-seizure drugs.

Research has shown that cannabidiol (CBD) can help reduce seizures in people with Lennox Gastaut Syndrome (LGS). One study reported a 43.9% reduction in monthly seizures for patients taking CBD, compared to 21.8% for those on a placebo. Another study found that 88% of participants felt their overall condition improved after using CBD. Long-term studies confirm that adding CBD to other treatments is safe and effective for managing seizures in LGS patients. In this trial, participants will receive the Cannabidiol Oral Solution, titrated up to a dose of 20 mg/kg per day or the maximum tolerated dose for 24 consecutive weeks. These findings suggest that CBD could be a promising option for reducing seizures in those with LGS.²⁶⁷⁸⁹