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NCT04391569 · ClinicalTrials.gov registry record · Phase 3
Randomized Therapy In Status Epilepticus
A Phase 3 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT04391569: Completed Phase 3 study, sponsored by Marinus Pharmaceuticals.
NCT04391569 is a Phase 3 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391569, a Phase 3 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).
Primary Outcome
SE cessation was determined by the investigator based on clinical and electroencephalography (EEG). Medications for the acute treatment of SE were defined as antiepileptic drugs (AEDs) administered to abort ongoing SE or prevent imminent recurrence of SE based on clinical or EEG evidence.
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2024-04-28 |
| Phase | Phase 3 |
What the finished NCT04391569 record still lists
NCT04391569 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04391569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04391569 about?
NCT04391569 is a clinical study titled "Randomized Therapy In Status Epilepticus". This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).
What is the current status of trial NCT04391569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2020-12-09. Estimated completion is 2024-04-28.
What interventions are being tested in trial NCT04391569?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT04391569?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04391569's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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