Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
Public ClinicalTrials.gov record NCT01963208. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults With Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01963208
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 405 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Type not available)
- Primary completion
- May 2016 (Actual)
- Completion
- Oct 2016 (Actual)
- Last update posted
- Feb 14, 2023
2013 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Epilepsy Center | Birmingham | Alabama | 35294-3280 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Xenoscience Inc. | Phoenix | Arizona | 85004 | — |
| The MORE Foundation | Sun City | Arizona | 85351 | — |
| Clinical Trials Inc. | Little Rock | Arkansas | 72205 | — |
| Neuro-Pain Medical Center, Inc | Fresno | California | 93710 | — |
| Neurological Research Institute | Santa Monica | California | 90404 | — |
| University of Colorado- Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | — |
| Neuroscience Consulants | Miami | Florida | 33176 | — |
| Medsol Clinical Research Center | Port Charlotte | Florida | 33952 | — |
| Consultants in Epilepsy & Neurology | Boise | Idaho | 83702 | — |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | 40504 | — |
| Mid-Atlantic Epilepsy Center | Bethesda | Maryland | 20817 | — |
| Bringham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | — |
| The Comprehensive Epilepsy Care Center for Children and Adults | Chesterfield | Missouri | 63017 | — |
| Cooper Medical Center of Rowan University | Camden | New Jersey | 08103 | — |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | — |
| Five Towns Neuroscience Research | Cedarhurst | New York | 11516 | — |
| Northeast Regional Epilepsy Group | Middletown | New York | 10941 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| New York University Comprehensive Epilepsy Center | New York | New York | 10016 | — |
| Northeast Regional Epilepsy Group | New York | New York | 10017 | — |
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio Clinical Research Partners, LLC | Canton | Ohio | 44718 | — |
| Ohio State University | Columbus | Ohio | 43221 | — |
| Lynn Health Institute | Oklahoma City | Oklahoma | 73112 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Jefferson Comprehensive Epilepsy Center | Philadelphia | Pennsylvania | 19107 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Neurology Consultants of Dallas | Dallas | Texas | 75231 | — |
| Texas Epilepsy Group | Dallas | Texas | 75251 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01963208, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01963208 live on ClinicalTrials.gov.