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NCT04721691 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04721691 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 16 participants.
The verdict
NCT04721691, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Epidiolex 100 mg/mL Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2024-01-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721691
The ClinicalTrials.gov registry entry for NCT04721691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04721691 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04721691 about?
NCT04721691 is a clinical study titled "Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).". 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 benzodia...
What is the current status of trial NCT04721691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-03-10. Estimated completion is 2024-01-17.
What interventions are being tested in trial NCT04721691?
The interventions under investigation include: Placebo (OTHER), Epidiolex 100 mg/mL Oral Solution (DRUG).
Who is sponsoring clinical trial NCT04721691?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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