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NCT01963208 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
A Phase 3 study of Drug Resistant Partial Onset Seizure, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
- 20
- Study locations
NCT01963208: Completed Phase 3 study of Drug Resistant Partial Onset Seizure, sponsored by Marinus Pharmaceuticals.
NCT01963208 is a Phase 3 study of Drug Resistant Partial Onset Seizure that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01963208, a Phase 3 study of Drug Resistant Partial Onset Seizure, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose. Primary anal
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ganaxolone
Study Locations (20)
Alabama
- University of Alabama Epilepsy Center - Birmingham
- University of Alabama at Birmingham - Birmingham
Arizona
- Xenoscience Inc. - Phoenix
- The MORE Foundation - Sun City
California
- Neuro-Pain Medical Center, Inc - Fresno
- Neurological Research Institute - Santa Monica
Florida
- Neuroscience Consulants - Miami
- Medsol Clinical Research Center - Port Charlotte
New Jersey
- Cooper Medical Center of Rowan University - Camden
- Northeast Regional Epilepsy Group - Hackensack
New York
- Five Towns Neuroscience Research - Cedarhurst
- Northeast Regional Epilepsy Group - Middletown
Arkansas
- Clinical Trials Inc. - Little Rock
Colorado
- University of Colorado- Anschutz Outpatient Pavilion - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT01963208 record still lists
NCT01963208 is an interventional study that assigns participants to a tested intervention. The registered 405 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 (48% lower).
The record links to 1 condition, with Drug Resistant Partial Onset Seizure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01963208 names 20 study sites across 14 states, led by Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01963208 about?
NCT01963208 is a clinical study titled "Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension". 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).
What is the current status of trial NCT01963208?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2013-10. Estimated completion is 2016-10.
What conditions does trial NCT01963208 study?
This clinical trial studies the following conditions: Drug Resistant Partial Onset Seizure.
What interventions are being tested in trial NCT01963208?
The interventions under investigation include: Placebo (DRUG), ganaxolone (DRUG).
Who is sponsoring clinical trial NCT01963208?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01963208 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01963208's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 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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