New pill aims to curb focal seizures in adults
NCT ID NCT07594119
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 7 times
Summary
This phase 3 study tests whether an investigational drug called RAP-219 can safely reduce the number of focal seizures in adults with epilepsy. About 312 participants will take either a low or medium dose of RAP-219 or a placebo pill daily. The main goal is to see if the drug lowers seizure frequency compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RAP-219 (an oral drug taken daily)
- What this could lead to
- If successful, RAP-219 could offer a new daily medication option to help people with focal seizures have fewer seizures.
- What could go wrong
- This is a phase 3 trial, but the drug is still investigational. It may not work better than placebo, and side effects are possible. Results may not apply to all epilepsy types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 312 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis 5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs 6. Ability to keep accurate daily focal seizure records using an e-diary Exclusion Criteria: 1. Known hypersensitivity or prior exposure to RAP-219. 2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur 3. Anticipated need for surgery during the study period 4. Medical history of any of the following: 1. generalized epilepsy 2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type 3. psychogenic nonepileptic seizure (PNES) 4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56). 5. epilepsy surgery within 12 months prior to Visit 1 (Day -56). 5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Clinic for Neurology
RECRUITINGHuntsville, Alabama, 35801, United States
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Colorado Springs Neurological Associates
RECRUITINGColorado Springs, Colorado, 80919, United States
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K2 Medical Research
RECRUITINGMaitland, Florida, 32751, United States
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Lenox Hill Hospital
RECRUITINGNew York, New York, 10075, United States
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Pillar Clinical Research
RECRUITINGBentonville, Arkansas, 72712, United States
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Re:Cognition Health-Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Serenity Research Center, LLC
RECRUITINGMiami, Florida, 33176, United States
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University of Texas Health Science Center in Houston
RECRUITINGHouston, Texas, 77030, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37179, United States
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Velocity Clinical Research
RECRUITINGRaleigh, North Carolina, 27607, United States
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