A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
Public ClinicalTrials.gov record NCT04244175. 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, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures (REALIZE Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if CVL-865, when taken regularly with other anti-seizure medicines, works to prevent seizures in adults with drug-resistant focal onset seizures. It will also learn about the safety of CVL-865. The main question it aims to answer is whether CVL-865, when taken regularly with other anti-seizure medicines, lowers the number of seizures in those with a diagnosis of epilepsy with drug-resistant focal onset seizures. This study has an 8-week Screening/Baseline Period, a 13-week Treatment Period (including a 2-week Titration Phase, an 8-week Maintenance Phase, and a 3-week Taper Phase), and a 4-week Safety Follow-Up Period. Participants will take CVL-865 or a placebo twice a day during the 10-13 week Treatment Period, visit the clinic every few weeks for checkups, tests, and surveys, and fill out an e-Diary.
Study identification
- NCT ID
- NCT04244175
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 154 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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 27, 2020 (Actual)
- Primary completion
- May 21, 2024 (Actual)
- Completion
- May 21, 2024 (Actual)
- Last update posted
- May 30, 2025
2020 – 2024
United States locations
- U.S. sites
- 37
- U.S. states
- 19
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Little Rock, Arkansas | Little Rock | Arkansas | 72205 | — |
| Downey, California | Downey | California | 90242 | — |
| Loma Linda, California | Loma Linda | California | 92354 | — |
| Valencia, California | Valencia | California | 91355 | — |
| New Haven, Connecticut | New Haven | Connecticut | 06520 | — |
| Altamonte Springs, Florida | Altamonte Springs | Florida | 32714 | — |
| Gulf Breeze, Florida | Gulf Breeze | Florida | 32561-4458 | — |
| Homestead, Florida | Homestead | Florida | 33032 | — |
| Jacksonville, Florida | Jacksonville | Florida | 32224 | — |
| Miami, Florida | Miami | Florida | 33136 | — |
| Miami Lakes, Florida | Miami Lakes | Florida | 33016 | — |
| Orlando, Florida | Orlando | Florida | 32806 | — |
| Port Charlotte, Florida | Port Charlotte | Florida | 33952 | — |
| Port Orange, Florida | Port Orange | Florida | 32127 | — |
| Tampa, Florida | Tampa | Florida | 33606 | — |
| Suwanee, Georgia, | Suwanee | Georgia | 30024 | — |
| Honolulu, Hawaii | Honolulu | Hawaii | 96817 | — |
| Lexington, Kentucky | Lexington | Kentucky | 40504 | — |
| Scarborough, Maine | Scarborough | Maine | 04074 | — |
| Baltimore, Maryland | Baltimore | Maryland | 21287 | — |
| Bethesda, Maryland | Bethesda | Maryland | 20817 | — |
| Boston, Massachusetts | Boston | Massachusetts | 02114 | — |
| Chesterfield, Missouri | Chesterfield | Missouri | 63005 | — |
| Saint Louis, Missouri | St Louis | Missouri | 63110 | — |
| Hackensack, New Jersey | Hackensack | New Jersey | 07601 | — |
| Mineola, New York | Mineola | New York | 11501 | — |
| New York | New York | New York | 10021 | — |
| Rochester, New York | Rochester | New York | 14642 | — |
| Syracuse, New York | Syracuse | New York | 13210 | — |
| Columbus, Ohio | Columbus | Ohio | 43221 | — |
| Toledo, Ohio | Toledo | Ohio | 43614 | — |
| Oklahoma City, Oklahoma | Oklahoma City | Oklahoma | 73112 | — |
| Philadelphia, Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia, Pennsylvania | Philadelphia | Pennsylvania | 19107 | — |
| Charleston, South Carolina | Charleston | South Carolina | 29425 | — |
| Nashville, Tennessee | Nashville | Tennessee | 37232 | — |
| Salt Lake City, Utah | Salt Lake City | Utah | 84108 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04244175, 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 May 30, 2025 · 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 NCT04244175 live on ClinicalTrials.gov.