Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures (FOCUS 2)

1. september 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 312 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (Medium Dosage, Low 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)

312

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Rekruttering
        • Clinic for Neurology
    • Arkansas
      • Bentonville, Arkansas, Forenede Stater, 72712
        • Rekruttering
        • Pillar Clinical Research
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80919
        • Rekruttering
        • Colorado Springs Neurological Associates
    • Florida
      • Maitland, Florida, Forenede Stater, 32751
        • Rekruttering
        • K2 Medical Research
      • Miami, Florida, Forenede Stater, 33176
        • Rekruttering
        • Serenity Research Center, LLC
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Re:Cognition Health-Chicago
    • New York
      • New York, New York, Forenede Stater, 10075
        • Rekruttering
        • Lenox Hill Hospital
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Rekruttering
        • Velocity Clinical Research
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37179
        • Rekruttering
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • University of Texas Health Science Center in Houston

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:

  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

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
Andet: Placebo
Matching placebo tablets administered orally
Eksperimentel: Active Arm- Medium Dose
RAP-219 daily tablets administered orally
Medicin: RAP-219
RAP-219 medium dose tablets administered orally daily
Medicin: RAP-219
RAP-219 low dose tablets administered orally daily
Eksperimentel: Active Arm-Low Dose
RAP-219 daily tablets administered orally
Medicin: RAP-219
RAP-219 medium dose tablets administered orally daily
Medicin: RAP-219
RAP-219 low 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
Incidence of Adverse Events
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

Rapport Therapeutics Inc.

Efterforskere

  • Ledende efterforsker: Vicente Villaneuva, M.D., PhD, Hospital Universitari i Politecnic La Fe, Spain

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 (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RAP-219-FOS-302

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner