A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
Public ClinicalTrials.gov record NCT00465517. 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 Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
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). 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.
Study identification
- NCT ID
- NCT00465517
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 147 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 69 Years
- 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
- Jan 31, 2007
- Primary completion
- Sep 30, 2008
- Completion
- Oct 31, 2008
- Last update posted
- Mar 14, 2023
2007 – 2008
United States locations
- U.S. sites
- 27
- U.S. states
- 22
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0021 | — |
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Arkansas Epilepsy Program | Little Rock | Arkansas | 72205 | — |
| University of Southern California Adult Comprehensive Epilepsy Center | Los Angeles | California | 90033 | — |
| University of California-Davis | Sacramento | California | 95817 | — |
| Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital | Aurora | Colorado | 80010-0045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| University of Florida McKnight Brain Institute | Gainesville | Florida | 32610-0236 | — |
| Intercoastal Medicine | Sarasota | Florida | 34232 | — |
| Emory HealthCare | Atlanta | Georgia | 30322 | — |
| Southern Illinois University Medical Center | Springfield | Illinois | 62702 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kentucky, Dept. of Neurology | Lexington | Kentucky | 40536 | — |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| 2799 West Grand blvd. CFP 071 | Detroit | Michigan | 48202 | — |
| Minnesota Epilepsy Group, PA | Saint Paul | Minnesota | 55102-2383 | — |
| Comprehensive Epilepsy Care Center for Children and Adults | Chesterfield | Missouri | 63017 | — |
| Overlook Hospital and Hackensack Medical Center | Hackensack | New Jersey | 07601 | — |
| Neurosciences Institute at Albany Medical Center | Albany | New York | 12208 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Riddle Health Care Center for Neuroscience | Media | Pennsylvania | 19063 | — |
| Drexel University / Hahneman Hospital | Philadelphia | Pennsylvania | 19102 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University Medical Ctr | Nashville | Tennessee | 37232 | — |
| Neurological Clinic of Texas, P.A. | Dallas | Texas | 75230 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00465517, 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 Mar 14, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00465517 live on ClinicalTrials.gov.