RAP-219 in adults with focal seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial randomizes about 333 adults with focal epilepsy to receive high-dose RAP-219, medium-dose RAP-219, or placebo in a 1:1:1 ratio during a double-blind treatment period. After this period, participants may enter an open-label extension for long-term safety or complete an 8-week post-treatment follow-up. Participants must be on 1–3 antiseizure medications and able to maintain daily seizure records using an electronic diary. The study aims to determine if RAP-219 can reduce focal seizure frequency while evaluating safety.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Amicis Research Center
  Palmdale, California, United States Recruiting
• Panhandle Research and Medical Clinic, LLC
  Gulf Breeze, Florida, United States Recruiting
• Emory Brain Health Center
  Atlanta, Georgia, United States Recruiting
• Consultants in Epilepsy & Neurology, PLLC
  Boise, Idaho, United States Recruiting
• Southern Illinois University Neurology Clinic
  Springfield, Illinois, United States Recruiting

Study contacts

• Study coordinator: Rapport Medical
• Email: RAP-219-FOS@rapportrx.com
• Phone: 857 323 9048

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RAP-219 for adults with focal seizures

  This study tests whether RAP-219 can reduce how often focal seizures happen in adults with focal epilepsy, compared with a placebo.

  Recruiting at 14 sites Phase 3 Rapport Therapeutics Inc. · Huntsville, Alabama and 13 other locations · NCT07594119

• Long-term RAP-219 treatment for adults with focal onset seizures

  This trial will try RAP-219, an investigational anti-seizure medication, in adults with refractory focal seizures to see if it is safe long-term and helps reduce seizures.

  Recruiting at 7 sites Phase 2 Rapport Therapeutics Inc. · Boise, Idaho and 6 other locations · NCT07219407

• Evaluating cognitive impairment in patients with focal cryptogenic epilepsy

  This study is testing how epilepsy affects thinking skills in people with different types of epilepsy to see if brain activity patterns can help understand their cognitive challenges better.

  Recruiting IRCCS San Raffaele · Milan · NCT06210022

• RAP-219 long-acting injectable safety and PK study in healthy adults

  This early study tests RAP-219-LAI in healthy adults to see how it behaves in the body and whether it is safe and tolerable.

  Recruiting Phase 1 Rapport Therapeutics Inc. · Adelaide · NCT07923097

• Why People with Epilepsy Get More Infections

  This study tests whether anti-seizure medicines affect immune function and infection risk in people with epilepsy.

  Recruiting University of Aberdeen · Aberdeen · NCT07903168

• Long-Term Epilepsy Outcomes in Children After Perinatal Stroke

  This study looks at how epilepsy progresses in kids who had a stroke before 28 days old to see how their seizures and syndromes evolve over time.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07898397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.