Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1 (FOCUS 1)
31. august 2026 opdateret af: Rapport Therapeutics Inc.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Approximately 333 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (High Dosage, Medium Dosage and Placebo).
After completing the Double-blind Treatment Period, participants will either transition into the RAP-219-FOS-901 long-term safety (open-label extension) study or enter the 8-week post-treatment Follow-up Period of this study.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
333
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rapport Medical
- Telefonnummer: 857 323 9048
- E-mail: RAP-219-FOS@rapportrx.com
Studiesteder
-
-
California
-
Palmdale, California, Forenede Stater, 91324
- Rekruttering
- Amicis Research Center
-
-
Florida
-
Gulf Breeze, Florida, Forenede Stater, 32561
- Rekruttering
- Panhandle Research and Medical Clinic, LLC
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30329
- Rekruttering
- Emory Brain Health Center
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83702
- Rekruttering
- Consultants in Epilepsy & Neurology, PLLC
-
-
Indiana
-
Fort Wayne, Indiana, Forenede Stater, 46804
- Rekruttering
- Indiana University Health Fort Wayne Neurology
-
-
Maryland
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Bethesda, Maryland, Forenede Stater, 20817
- Rekruttering
- Mid-Atlantic Epilepsy and Sleep Center
-
-
New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Rekruttering
- Northeast Regional Epilepsy Group
-
-
North Carolina
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Asheville, North Carolina, Forenede Stater, 28806
- Rekruttering
- Asheville Neurology Specialists
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44109
- Rekruttering
- Cleveland Clinic
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Thomas Jefferson University
-
-
Virginia
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Richmond, Virginia, Forenede Stater, 23236
- Rekruttering
- Neurological Associates
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known hypersensitivity or prior exposure to RAP-219.
- Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Inert komparator, der matcher den aktive behandling
|
Matching placebo tablets administered orally daily
|
|
Eksperimentel: Active Arm- High Dose
RAP-219 daily tablets administered orally
|
RAP-219 high dose tablets administered orally daily
RAP-219 medium dose tablets administered orally daily
|
|
Eksperimentel: Active Arm- Medium Dose
RAP-219 daily tablets administered orally
|
RAP-219 high dose tablets administered orally daily
RAP-219 medium dose tablets administered orally daily
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Median Percent Change in Seizure Frequency
Tidsramme: End of double-blind treatment period (end of week 14) vs Baseline
|
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
|
End of double-blind treatment period (end of week 14) vs Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
≥50% seizure frequency reduction responder rates
Tidsramme: End of double-blind treatment period (end of week 14) vs Baseline.
|
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
|
End of double-blind treatment period (end of week 14) vs Baseline.
|
|
Longest Seizure Free Interval
Tidsramme: Across the entire 14-week double-blind treatment period
|
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
|
Across the entire 14-week double-blind treatment period
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
RAP-219 safety and tolerability
Tidsramme: From Visit 1 through End of Study, on average Week 22.
|
incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs leading to discontinuation
|
From Visit 1 through End of Study, on average Week 22.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. juni 2026
Primær færdiggørelse (Anslået)
1. juli 2029
Studieafslutning (Anslået)
1. september 2029
Datoer for studieregistrering
Først indsendt
16. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
4. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RAP-219-FOS-301
Plan for individuelle deltagerdata (IPD)
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