CompletedPhase 1

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

United States16 participantsStarted 2021-03-10

Plain-language 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.

Who can participate

Age range2 Years – 17 Years

SexALL

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Exclusion criteria

✕. Previous use of cannabidiol within 4 months.
✕. Pregnancy or lactation
✕. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose
✕. Febrile illness within 1 month of screening
✕. Treatment with another investigational drug or other intervention within 6 months
✕. Current smoker or tobacco use within 6 months

What they're measuring

Frequency of Spike Wave Index

Timeframe: Up to 20 weeks

Trial details

NCT IDNCT04721691

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-17

View on ClinicalTrials.gov More Electrical Status Epilepticus of Slow-Wave Sleep trials