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NCT00465517 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT00465517: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT00465517 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00465517, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
Primary Outcome
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)\] during Weeks 1 through 10.
Interventions
- OTHER Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT00465517 record still lists
NCT00465517 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00465517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00465517 about?
NCT00465517 is a clinical study titled "A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures". The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. ...
What is the current status of trial NCT00465517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2007-02. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00465517?
The interventions under investigation include: Placebo (OTHER), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT00465517?
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 NCT00465517's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 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
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