Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00512317 · ClinicalTrials.gov registry record · Phase 2
Open-label Extension to Protocol 1042-0600
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00512317: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT00512317 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00512317, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
To allow open-label extension to patients who have completed Protocol 1042-0600.
Primary Outcome
Percent Change in weekly seizure frequency by treatment group compared to Baseline at the beginning of the double-blind study 1042-0600 is presented. Weekly seizure frequency included partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS) during Weeks 1 through Week 117. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Interventions
- DRUG ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT00512317 record still lists
NCT00512317 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which ganaxolone is the first listed.
NCT00512317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00512317 about?
NCT00512317 is a clinical study titled "Open-label Extension to Protocol 1042-0600". To allow open-label extension to patients who have completed Protocol 1042-0600.
What is the current status of trial NCT00512317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2007-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00512317?
The interventions under investigation include: ganaxolone (DRUG).
Who is sponsoring clinical trial NCT00512317?
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 NCT00512317's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT05285891 · 123 participants · Phase 4
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
- NCT05334368 · 123 participants · Phase 3
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
- NCT06088355 · 123 participants · NA
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
- NCT06111131 · 123 participants · NA
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia