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Taking peoplePhase 3

RAP-219 for Adults With Focal Seizures

Tests RAP-219 for reducing seizures in adults with focal epilepsy.

Key facts

Who runs it
Rapport Therapeutics Inc.
Where
DO NOT EDIT, IrelandSee the siteAlso in 11 other countries, 40 sites
Registry title
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Status
Recruiting
Phase
Phase 3
People taking part
333 people, planned
Started
5 Jun 2026
Expected to end
Sept 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • RAP-219
  • Placebo
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with focal epilepsy who take 1 to 3 antiseizure medicines. It tests whether RAP-219 safely reduces how often focal seizures happen.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Focal epilepsy diagnosed at least 24 months before the first visit. A brain MRI or CT scan and an EEG, each done within the last 10 years, must fit focal epilepsy.
Earlier treatment
Must be taking between 1 and 3 antiseizure medicines as regular treatment. Rescue or as-needed medicines do not count. Must not have had RAP-219 before.

Main reasons for not taking part

  • Known allergy to RAP-219 or earlier exposure to it
  • Serious medical, nerve or mental health condition that is not stable
  • Generalized epilepsy, psychogenic nonepileptic seizures, or only focal aware nonmotor seizures
  • Status epilepticus, seizure clusters or epilepsy surgery in the past 12 months
  • Another investigational drug trial within 12 weeks or 5 half-lives

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Age 18 - 75
  • BMI 18-45 kg/m2
  • Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
  • 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
  • Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
  • Ability to keep accurate daily focal seizure records using an e-diary

Who cannot take part

  • Known hypersensitivity or prior exposure to RAP-219
  • Anticipated need for surgery during the study period
  • Medical history of any of the following:; generalized epilepsy; focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type; psychogenic nonepileptic seizure (PNES); status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56); epilepsy surgery within 12 months prior to Visit 1 (Day -56)
  • Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
  • Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Ireland

Also in 11 other countries, 40 sites

  • Article 11 CTR IEDO NOT EDIT, IrelandNot yet recruiting

About the trial

What the trial wants to find out

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

The 3 groups in the trial

  • Active Arm- High DoseTreatment being tested

    RAP-219 daily tablets administered orally

    Treatment: RAP-219

  • Active Arm- Medium DoseTreatment being tested

    RAP-219 daily tablets administered orally

    Treatment: RAP-219

  • PlaceboPlacebo, for comparison

    Inert comparator matching the active treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Plain-language title
RAP-219 for Adults With Focal SeizuresGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07563881, who can take part
Record updated
12 November 2026