Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
Public ClinicalTrials.gov record NCT03678753. 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 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With PGTC Seizures
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study.
Study identification
- NCT ID
- NCT03678753
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 169 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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 3, 2018 (Actual)
- Primary completion
- May 26, 2025 (Actual)
- Completion
- May 26, 2025 (Actual)
- Last update posted
- Jul 2, 2026
2018 – 2025
United States locations
- U.S. sites
- 43
- U.S. states
- 26
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Center for Neurosciences | Tuscon | Arizona | 85718 | — |
| Neuro Pain Medical Center | Fresno | California | 93710 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Children's Hospital of Colorado | Grand Junction | Colorado | 80045 | — |
| Brainstorm Research | Miami | Florida | 33176 | — |
| Florida Hospital Medical Group | Orlando | Florida | 32803 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Clinical Integrative Research Center of Atlanta, CIRCA | Atlanta | Georgia | 30328 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96814 | — |
| Consultants in Epilepsy and Neurology | Boise | Idaho | 83702 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| PMG Research of McFarland Clinic | Ames | Iowa | 50010 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Maine Medical Center | Scarborough | Maine | 04074 | — |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| Minneapolis Clinic of Neurology Golden Valley | Golden Valley | Minnesota | 55422 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| University of Missouri Health Care | Columbia | Missouri | 65201 | — |
| JFK Medical Center- The Neuroscience Institute | Edison | New Jersey | 08818 | — |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| New York Presbyterian Hospital | Brooklyn | New York | 11215 | — |
| UBMD Neurology | Buffalo | New York | 14203 | — |
| Five Towns Neuroscience Research | Woodmere | New York | 11598 | — |
| Duke University Children's Health Center | Durham | North Carolina | 27710 | — |
| Ohio Health Research and Innovation Institute | Columbus | Ohio | 43214 | — |
| University of Toledo | Toledo | Ohio | 43606 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Lewis Katz School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| LeBonheur Children's Medical Center | Memphis | Tennessee | 38105 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Child Neurology Consultants of Austin | Austin | Texas | 78757 | — |
| ANRC Research | El Paso | Texas | 79912 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah / Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Carilion Clinic | Roanoke | Virginia | 24016 | — |
| Valley Medical Center | Renton | Washington | 98057 | — |
| MultiCare Institute for Research and Innovation | Spokane | Washington | 99204 | — |
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 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03678753, 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 Jul 2, 2026 · 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 NCT03678753 live on ClinicalTrials.gov.