Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Northwell Health.
NCT04721691 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess the reduction in spike wave index by evaluating the differences in activity from the four 24-hour ambulatory EEGs each participant obtains while enrolled in this study
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 |
What the finished NCT04721691 record still lists
NCT04721691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04721691 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04721691's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI