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NCT02519439 · ClinicalTrials.gov registry record · Phase 3
A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures
A Phase 3 study, sponsored by Marinus Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT02519439: Clinical Trial Phase 3 study, sponsored by Marinus Pharmaceuticals.
NCT02519439 is a Phase 3 study that was terminated before completion, run by Marinus Pharmaceuticals. The registered enrollment target is 26 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02519439, a Phase 3 study, was terminated before completion, sponsored by Marinus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study Summary
A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult patients with drug-resistant partial-onset seizures
Primary Outcome
Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period of Study 1042-0603 (less than or equal to 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Post-baseline 28-day seizure frequency was calculated as the number of seizures in the entire treatment period divided by the number of days with available seizure data in the treatment period and multiplied by 28. Baseline was defined as the last
Interventions
- DRUG ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
Why NCT02519439 stopped before completion
NCT02519439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which ganaxolone is the first listed.
NCT02519439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02519439 about?
NCT02519439 is a clinical study titled "A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures". A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult patients with drug-resistant partial-onset seizures
What is the current status of trial NCT02519439?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2015-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02519439?
The interventions under investigation include: ganaxolone (DRUG).
Who is sponsoring clinical trial NCT02519439?
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 NCT02519439's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 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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