Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

26. august 2026 oppdatert av: Kallyope Inc.
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1000

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Rekruttering
        • Central Research Associates, LLC (CRA) dba Flourish Research
      • Mobile, Alabama, Forente stater, 36608
        • Rekruttering
        • AMR Mobile
    • Arizona
      • Chandler, Arizona, Forente stater, 85286
        • Rekruttering
        • TrialSphere
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Rekruttering
        • Arkansas Clinical Research
    • California
      • Colton, California, Forente stater, 92324
        • Rekruttering
        • Axiom Research, LLC
      • Culver City, California, Forente stater, 90230
        • Rekruttering
        • Proscience Research Group
      • Encino, California, Forente stater, 91316
        • Rekruttering
        • Leading Edge Research LA, LLC
      • Irvine, California, Forente stater, 92604
        • Rekruttering
        • Axiom Research, Orange County
      • Los Angeles, California, Forente stater, 90048
        • Rekruttering
        • Clinical Research Institute
      • Los Angeles, California, Forente stater, 90017
        • Rekruttering
        • Downtown L.A. Research Center, Inc.
      • Mission Viejo, California, Forente stater, 92691
        • Rekruttering
        • M3 Wake Research - Mission Mental Health (WR-MMH)
      • Oceanside, California, Forente stater, 92056
        • Rekruttering
        • Excell Research
      • Pomona, California, Forente stater, 91767
        • Rekruttering
        • The Neurology Group
      • Pomona, California, Forente stater, 91767
        • Rekruttering
        • Empire Clinical Research
      • Riverside, California, Forente stater, 92503
        • Rekruttering
        • Artemis Institute for Clinical Research
      • San Diego, California, Forente stater, 92120
        • Rekruttering
        • Acclaim Clinical Research
      • Sherman Oaks, California, Forente stater, 91403
        • Rekruttering
        • CenExel Sherman Oaks CA (California Neuroscience Research)
      • Spring Valley, California, Forente stater, 91978
        • Rekruttering
        • Encompass Clinical Research
      • Walnut Creek, California, Forente stater, 94598
        • Rekruttering
        • Diablo Clinical Research
      • Walnut Creek, California, Forente stater, 94596
        • Rekruttering
        • Sunwise Clinical Research
      • West Covina, California, Forente stater, 91790
        • Rekruttering
        • Kinetic Clinical Research
      • West Hills, California, Forente stater, 91307
        • Rekruttering
        • Focus Clinical Research
    • Colorado
      • Centennial, Colorado, Forente stater, 80112
        • Rekruttering
        • IMMUNOe Research Centers
      • Colorado Springs, Colorado, Forente stater, 80910
        • Rekruttering
        • MCB Clinical Research Centers
      • Fort Collins, Colorado, Forente stater, 80528
        • Rekruttering
        • Advanced Neurosciences Research
    • Connecticut
      • Waterbury, Connecticut, Forente stater, 06708
        • Rekruttering
        • Chase Medical Research, LLC
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • Rekruttering
        • DelRicht Research
      • Marietta, Georgia, Forente stater, 30060
        • Rekruttering
        • Drug Studies America
      • Stockbridge, Georgia, Forente stater, 30281
        • Rekruttering
        • Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
    • Illinois
      • Chicago, Illinois, Forente stater, 60607
        • Rekruttering
        • Cedar Crosse Research Center
      • Chicago, Illinois, Forente stater, 60657
        • Rekruttering
        • Chicago Headache Center & Research Institute
      • Flossmoor, Illinois, Forente stater, 60447
        • Rekruttering
        • Healthcare Research Network II, LLC
      • Naperville, Illinois, Forente stater, 60563
        • Rekruttering
        • Chicago Headache Center & Research Institute
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50265
        • Rekruttering
        • Integrated Clinical Trials Solution
    • Kansas
      • Overland Park, Kansas, Forente stater, 66214
        • Rekruttering
        • Clinical Associates Midwest, LLC
      • Overland Park, Kansas, Forente stater, 66212
        • Rekruttering
        • Collective Medical Research
      • Wichita, Kansas, Forente stater, 67207
        • Rekruttering
        • Heartland Research Associates, LLC - An AMR Company
    • Kentucky
      • Bardstown, Kentucky, Forente stater, 40004
        • Rekruttering
        • Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
      • Lexington, Kentucky, Forente stater, 40509
        • Rekruttering
        • AMR Clinical - Lexington
      • Lexington, Kentucky, Forente stater, 45212
        • Rekruttering
        • CTI Clinical Research Center
    • Louisiana
      • Chalmette, Louisiana, Forente stater, 70043
        • Rekruttering
        • Crescent City Headache & Neurology Center
      • New Orleans, Louisiana, Forente stater, 70115
        • Rekruttering
        • DelRicht Research
    • Maryland
      • Pikesville, Maryland, Forente stater, 21208
        • Rekruttering
        • Headlands Research - Pharmasite
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02131
        • Rekruttering
        • Boston Clinical Trials - Alcanza
      • Waltham, Massachusetts, Forente stater, 02451
        • Rekruttering
        • MedVadis Research Corporation, LLC
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48104
        • Rekruttering
        • Michigan Headache Pain & Neurological Institute
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Rekruttering
        • Clinical Research Institute
    • Mississippi
      • Gulfport, Mississippi, Forente stater, 39503
        • Rekruttering
        • DelRicht Research
      • Ridgeland, Mississippi, Forente stater, 39157
        • Rekruttering
        • Proven Endpoints
    • Missouri
      • City of Saint Peters, Missouri, Forente stater, 63303
        • Rekruttering
        • StudyMetrix Research
      • Hazelwood, Missouri, Forente stater, 63042
        • Rekruttering
        • Healthcare Research Network
      • Kansas City, Missouri, Forente stater, 64114
        • Rekruttering
        • AMR Clinical - Kansas City
      • Springfield, Missouri, Forente stater, 65807
        • Rekruttering
        • Clinvest Headlands Llc
      • St Louis, Missouri, Forente stater, 63141
        • Rekruttering
        • Sundance Clinical Research
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89109
        • Rekruttering
        • Excel Clinical Research
      • Las Vegas, Nevada, Forente stater, 89119
        • Rekruttering
        • Redbird Research
      • Las Vegas, Nevada, Forente stater, 89102
        • Rekruttering
        • Ima Clinical Research - Las Vegas
      • Las Vegas, Nevada, Forente stater, 89118
        • Rekruttering
        • Wake Research Las Vegas Rainbow
      • Las Vegas, Nevada, Forente stater, 89119
        • Rekruttering
        • AMR Clinical - Las Vegas
      • North Las Vegas, Nevada, Forente stater, 89030
        • Rekruttering
        • Las Vegas Clinical Trials
      • Reno, Nevada, Forente stater, 89511
        • Rekruttering
        • Advanced Research Institute-Reno
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Rekruttering
        • Albuquerque Clinical Trials
    • New York
      • Amherst, New York, Forente stater, 14226
        • Rekruttering
        • Dent Neuro Institute, Buffalo
      • Brooklyn, New York, Forente stater, 11235
        • Rekruttering
        • SPRI Clinical Trials, LLC
      • Commack, New York, Forente stater, 11725
        • Rekruttering
        • True North Neurology
      • Manlius, New York, Forente stater, 13104
        • Rekruttering
        • Central New York Clinical Research
      • New York, New York, Forente stater, 10017
        • Rekruttering
        • Fieve Clinical Research, Inc
      • Rochester, New York, Forente stater, 14609
        • Rekruttering
        • Rochester Clinical Research
      • Williamsville, New York, Forente stater, 14221
        • Rekruttering
        • Upstate Clinical Research Associates
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28277
        • Rekruttering
        • Onsite Clinical Solutions
      • Greensboro, North Carolina, Forente stater, 27405
        • Rekruttering
        • Headache Wellness Center
      • Greensboro, North Carolina, Forente stater, 27405
        • Rekruttering
        • Guilford Neurologic Research Partners, LLC
      • Raleigh, North Carolina, Forente stater, 27607
        • Rekruttering
        • Eximia Research - NC, LLC
      • Shelby, North Carolina, Forente stater, 28150
        • Rekruttering
        • Carolina Research Center, Inc
    • Ohio
      • Columbus, Ohio, Forente stater, 43228
        • Rekruttering
        • Hometown Research
      • Milford, Ohio, Forente stater, 45150
        • Rekruttering
        • Hometown Research
      • West Chester, Ohio, Forente stater, 45069
        • Rekruttering
        • CincyScience
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73034
        • Rekruttering
        • OK Clinical Research, LLC
      • Oklahoma City, Oklahoma, Forente stater, 73102
        • Rekruttering
        • Hightower Clinical
      • Tulsa, Oklahoma, Forente stater, 74133
        • Rekruttering
        • DelRicht Research
      • Yukon, Oklahoma, Forente stater, 73099
        • Rekruttering
        • Tekton Research, Inc.
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Rekruttering
        • Summit Research Network
      • Portland, Oregon, Forente stater, 97223
        • Rekruttering
        • Advanced Research Institute-Portland
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Rekruttering
        • Lehigh Center For Clinical Research
      • Philadelphia, Pennsylvania, Forente stater, 19114
        • Rekruttering
        • Clinical Research Philadelphia
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • Rekruttering
        • Preferred Primary Care Physicians, Inc.
      • Scottdale, Pennsylvania, Forente stater, 15683
        • Rekruttering
        • Frontier Clinical Research, LLC
      • Smithfield, Pennsylvania, Forente stater, 15478
        • Rekruttering
        • Frontier Clinical Research, LLC
    • South Carolina
      • North Charleston, South Carolina, Forente stater, 29405
        • Rekruttering
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37421
        • Rekruttering
        • WR-ClinSearch, LLC
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Clinical Research Associates, Inc.
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Access Clinical Trials Inc
    • Texas
      • Austin, Texas, Forente stater, 78731
        • Rekruttering
        • FutureSearch Trials of Neurology
      • Austin, Texas, Forente stater, 78745
        • Rekruttering
        • Tekton Research
      • Cypress, Texas, Forente stater, 77372
        • Rekruttering
        • APD Clinical Research
      • Cypress, Texas, Forente stater, 77429
        • Rekruttering
        • Horizon Clinical Research and Gill Neuroscience
      • Dallas, Texas, Forente stater, 75251
        • Rekruttering
        • FutureSearch Trials of Dallas, LP
      • Houston, Texas, Forente stater, 77081
        • Rekruttering
        • DM Clinical Research
      • Houston, Texas, Forente stater, 77024
        • Rekruttering
        • Victorium Clinical Research
      • Lampasas, Texas, Forente stater, 76550
        • Rekruttering
        • GMG Clinical Research, LLC dba Radiance Clinical Research
      • Plano, Texas, Forente stater, 75093
        • Rekruttering
        • AIM Trials, LLC
      • Waxahachie, Texas, Forente stater, 75165
        • Rekruttering
        • ClinPoint Trials
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • Rekruttering
        • Pantheon Clinical Research
      • Draper, Utah, Forente stater, 84020
        • Rekruttering
        • J. Lewis Research, Inc. / Foothill Family Clinic Draper
      • Ogden, Utah, Forente stater, 84405
        • Rekruttering
        • Advanced Research Institute
      • Riverton, Utah, Forente stater, 84096
        • Rekruttering
        • Granger Medical Clinic
      • Salt Lake City, Utah, Forente stater, 84109
        • Rekruttering
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, Forente stater, 84121
        • Rekruttering
        • J. Lewis Research, Inc. / Foothill Family Clinic
    • Virginia
      • Newport News, Virginia, Forente stater, 23606
        • Rekruttering
        • Health Research of Hampton Roads, Inc. (HRHR)
      • Norfolk, Virginia, Forente stater, 23502
        • Rekruttering
        • AMR Clinical - Norfolk
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Rekruttering
        • Seattle Clinical Research Center
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26505
        • Rekruttering
        • Frontier Clinical Research
    • Wisconsin
      • Kenosha, Wisconsin, Forente stater, 53144
        • Rekruttering
        • Clinical Investigation Specialists, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.

    Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was <80%;

  2. Participant voluntarily agrees to participate in the study by giving written informed consent;
  3. Participant is able to read, understand, and complete the study questionnaires and diary;
  4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
  5. Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;
  6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.

Acceptable methods of birth control are:

i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).

  • Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

  1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
  2. Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);
  3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;
  4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3;
  5. Has any major surgery scheduled for the duration of the trial;
  6. Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and/or safety results;
  7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
  8. Experienced a serious adverse event in the base study;
  9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Elismetrep 10 mg
Legemiddel: Placebo
Administreres oralt
Legemiddel: Elismetrep
Administered orally
Andre navn:
  • K-304
Eksperimentell: Elismetrep 20 mg
Legemiddel: Elismetrep
Administered orally
Andre navn:
  • K-304

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Tidsramme: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with at least one treatment-emergent serious adverse event (SAE)
Tidsramme: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with TEAEs leading to study drug discontinuation
Tidsramme: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm
Tidsramme: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kallyope Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. august 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • K-304 P005

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere