drugset / Trial / NCT04721691
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
RandomizedCrossoverDouble-blindTreatment
Summary
This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.
Timeline
- Start
- 2021-03-10
- Primary completion
- 2024-01-17
- Completion
- 2024-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cannabidiol | Other / unclassified | 10 mg/kg | Oral |
| Comparator | Cannabidiol | Other / unclassified | 20 mg/kg | Oral |