Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy

Summary

This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor (generalized, focal, or both) seizures in children and young adults with rare disease-associated severe epilepsy. Secondary objectives include assessment of safety and tolerability, changes in behaviour, cognition and sleep, pharmacokinetic interaction with concurrent ASMs.

Timeline

Start

2023-06-01

Primary completion

2025-03-01

Completion

2025-03-01

Drugs

Indications