drugset / Trial / NCT04721691

Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

NCT04721691

Phase 1 Completed 16 enrolled Northwell Health Jazz Pharmaceuticals · collab
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

EvaluationDrugModalityDoseRoute
Comparator Cannabidiol Other / unclassified 10 mg/kg Oral
Comparator Cannabidiol Other / unclassified 20 mg/kg Oral