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A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine

11. november 2026 oppdatert av: TriGemX Bio, Inc.

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Rekruttering

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
1500

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studiesteder

  • Forente stater
    • Arizona
      • Glendale, Arizona, Forente stater, 85304
        • Har ikke rekruttert ennå
        • Sun City Clinical Research
        • Ta kontakt med:
      • Phoenix, Arizona, Forente stater, 85006
        • Rekruttering
        • Velocity Clinical Research, Phoenix
        • Ta kontakt med:
      • Phoenix, Arizona, Forente stater, 85012
        • Rekruttering
        • IMA Clinical Research - Phoenix
        • Ta kontakt med:
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Rekruttering
        • Preferred Research Partners, Inc.
        • Ta kontakt med:
    • California
      • Canoga Park, California, Forente stater, 91304
        • Rekruttering
        • Alliance Research Institute, Canoga Park
        • Ta kontakt med:
      • Chula Vista, California, Forente stater, 91911
        • Rekruttering
        • Velocity Clinical Research, Chula Vista
        • Ta kontakt med:
      • Fountain Valley, California, Forente stater, 92708
        • Rekruttering
        • Ark Clinical Research, Fountain Valley
        • Ta kontakt med:
      • Fullerton, California, Forente stater, 92835
        • Rekruttering
        • Neurology Center of North Orange County
        • Ta kontakt med:
      • Glendale, California, Forente stater, 91206
      • Long Beach, California, Forente stater, 90806
        • Rekruttering
        • Long Beach Clinical Trials Services, Inc
        • Ta kontakt med:
      • Long Beach, California, Forente stater, 90807
        • Rekruttering
        • Accellacare - Long Beach
        • Ta kontakt med:
      • Lynwood, California, Forente stater, 90262
        • Rekruttering
        • Alliance Research Institute, Lynwood
        • Ta kontakt med:
      • Northridge, California, Forente stater, 91325
        • Har ikke rekruttert ennå
        • Northridge Clinical Trials
        • Ta kontakt med:
      • Pasadena, California, Forente stater, 91101
        • Rekruttering
        • Pasadena Clinical Trials
        • Ta kontakt med:
      • Redding, California, Forente stater, 96001
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92108
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92108
      • San Francisco, California, Forente stater, 94102
        • Rekruttering
        • Optimus Medical Group
        • Ta kontakt med:
      • Santa Ana, California, Forente stater, 92703
      • Van Nuys, California, Forente stater, 91606
        • Rekruttering
        • Velocity Clinical Research, Van Nuys
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80012
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC; Aurora
        • Ta kontakt med:
      • Denver, Colorado, Forente stater, 80246
    • Connecticut
      • Stamford, Connecticut, Forente stater, 06905-1206
        • Rekruttering
        • Ki Health Partners, LLC
        • Ta kontakt med:
    • Florida
      • Hallandale, Florida, Forente stater, 33009
        • Rekruttering
        • Velocity Clinical Research, Hallandale Beach
        • Ta kontakt med:
      • Lakeland, Florida, Forente stater, 33805
        • Rekruttering
        • Clinical Research of Central Florida
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33155
      • Ocoee, Florida, Forente stater, 34761
      • Orlando, Florida, Forente stater, 32819
      • Tampa, Florida, Forente stater, 33613
        • Rekruttering
        • Cenexel Tampa FL
        • Ta kontakt med:
      • West Palm Beach, Florida, Forente stater, 33407
        • Rekruttering
        • Premiere Research Institute at Palm Beach Neurology
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30328
        • Rekruttering
        • Clinical Integrative Research Center of Atlanta
        • Ta kontakt med:
      • Norcross, Georgia, Forente stater, 30092
      • Savannah, Georgia, Forente stater, 31406
        • Rekruttering
        • Velocity Clinical Research, Savannah
        • Ta kontakt med:
    • Idaho
      • Boise, Idaho, Forente stater, 83709
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC
        • Ta kontakt med:
    • Illinois
      • Gurnee, Illinois, Forente stater, 60031
        • Rekruttering
        • Clinical Investigation Specialists, Inc.
        • Ta kontakt med:
      • Skokie, Illinois, Forente stater, 60077
        • Rekruttering
        • Evanston Premier Healthcare Research, LLC
        • Ta kontakt med:
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46254
      • Merrillville, Indiana, Forente stater, 46410
    • Iowa
      • Ames, Iowa, Forente stater, 50010
      • Sioux City, Iowa, Forente stater, 51106
        • Rekruttering
        • Velocity Clinical Research, Sioux City
        • Ta kontakt med:
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02721
        • Rekruttering
        • NECCR PrimaCare Research, LLC
        • Ta kontakt med:
      • Foxborough, Massachusetts, Forente stater, 02035
        • Rekruttering
        • Neurology Center of New England P.C.
        • Ta kontakt med:
    • Montana
      • Missoula, Montana, Forente stater, 59808
    • Nebraska
      • Norfolk, Nebraska, Forente stater, 68701
        • Rekruttering
        • Velocity Clinical Research, Norfolk
        • Ta kontakt med:
      • Omaha, Nebraska, Forente stater, 68114
        • Rekruttering
        • Quality Clinical Research, Inc.
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89121
        • Rekruttering
        • Oasis Clinical Research
        • Ta kontakt med:
    • New Jersey
      • Toms River, New Jersey, Forente stater, 08755
        • Rekruttering
        • Bio Behavioral Health
        • Ta kontakt med:
          • Ashok Patel
          • Telefonnummer: 732-244-2299
          • E-post: ap@bbhnj.com
    • North Carolina
      • Cary, North Carolina, Forente stater, 27518
        • Rekruttering
        • Accellacare - Cary (Cary Medical Group)
        • Ta kontakt med:
      • Morehead City, North Carolina, Forente stater, 28557
      • Raleigh, North Carolina, Forente stater, 27609
        • Rekruttering
        • Accellacare - Raleigh (Raleigh Medical Group, P.A.)
        • Ta kontakt med:
      • Wilmington, North Carolina, Forente stater, 28401
      • Winston-Salem, North Carolina, Forente stater, 27103
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58104
    • Ohio
      • Beachwood, Ohio, Forente stater, 44122
        • Rekruttering
        • Velocity Clinical Research, Cleveland
        • Ta kontakt med:
      • Blue Ash, Ohio, Forente stater, 45242
        • Rekruttering
        • Velocity Clinical Research, Cincinnati, Blue Ash
        • Ta kontakt med:
      • Cincinnati, Ohio, Forente stater, 45236
        • Rekruttering
        • Headache Center of Hope
        • Ta kontakt med:
      • Columbus, Ohio, Forente stater, 43213
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02818
        • Rekruttering
        • Velocity Clinical Research, Providence
        • Ta kontakt med:
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
      • Gaffney, South Carolina, Forente stater, 29340
        • Rekruttering
        • Velocity Clinical Research, Gaffney
        • Ta kontakt med:
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Rekruttering
        • Central Texas Clinical Research
        • Ta kontakt med:
      • Beaumont, Texas, Forente stater, 77702
        • Rekruttering
        • Gadolin Research, LLC
        • Ta kontakt med:
      • Dallas, Texas, Forente stater, 75230
        • Rekruttering
        • Velocity Clinical Research, Dallas
        • Ta kontakt med:
      • DeSoto, Texas, Forente stater, 75115
        • Rekruttering
        • Epic Medical Research - DeSoto
        • Ta kontakt med:
      • El Paso, Texas, Forente stater, 79902
        • Rekruttering
        • Newco 3A Researh LLC, DBA 3A Research
        • Ta kontakt med:
      • Lake Jackson, Texas, Forente stater, 77566
      • San Antonio, Texas, Forente stater, 78240
        • Rekruttering
        • San Antonio Clinical Trials
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • Clinical Trials of Texas, LLC, A Flourish Research Site
        • Ta kontakt med:
      • Sugar Land, Texas, Forente stater, 77479
        • Rekruttering
        • DM Clinical Research, Sugar Land
        • Ta kontakt med:
      • Tomball, Texas, Forente stater, 77375
        • Rekruttering
        • DM Clinical Research, Tomball
        • Ta kontakt med:
    • Utah
      • Salt Lake City, Utah, Forente stater, 84107
        • Rekruttering
        • Wasatch Clinical Research, LLC
        • Ta kontakt med:
      • Salt Lake City, Utah, Forente stater, 84124
        • Rekruttering
        • Highland Clinical Research
        • Ta kontakt med:

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

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent.

2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated as documented in the patient's medical records from his/her treating physician or with pharmacy records confirming use of a migraine-specific medication (e.g. triptan, gepant, ditan) for > 1 year, and confirmed by the investigator. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:

a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:

  1. A minimum of 12 months of spontaneous amenorrhea or
  2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
  3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the subject's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity* OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.

Acceptable methods of birth control are:

  1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
  2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
  3. Intrauterine device (IUD);
  4. Intrauterine hormone-releasing system (IUS);
  5. Bilateral tubal occlusion;
  6. Vasectomized partner;
  7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
  8. Male or female condom with or without spermicide;
  9. Cap, diaphragm or sponge with spermicide;
  10. 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 subject'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.

5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.

Exclusion Criteria:

Patients are excluded from the trial if any of the following criteria apply:

  1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.

    Migraine history-related

  2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.

  3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.

  4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).

  5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.

  6. Was >50 years old at age of first migraine onset.

  7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.

    Medical history related

  8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].

  9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients 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 the past 2 months or suicidal behavior in the past 6 months.

  10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.

  11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.

  12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.

  13. Has a history of human immunodeficiency virus disease.

  14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption.

    Laboratory, vital sign, and electrocardiogram related

  15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.

  16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.

  17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.

  18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.

  19. Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.

    Medication use and substance abuse related

  20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.

  21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD) within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.

  22. Has a positive drug screen at screening. Note:

    1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
    2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.

  23. 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 study participation (detailed in the protocol).

  24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.

  25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.

  26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.

    Other

  27. Has known or suspected hypersensitivity to trial product(s) or related products.

  28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.

  29. Has any surgery scheduled for the duration of the trial.

  30. Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).

  31. Has previous participation in this trial. Participation is defined as signed informed consent.

  32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P003. Note: Patients may not be screened at more than one trial site for this study.

  33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.

  34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site. Note: Rescreening/retesting is not permitted unless specified above.

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

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: Elismetrep 10 mg

Participants received a single dose of elismetrep 10 mg
Legemiddel: Elismetrep

Administered orally

Andre navn:
  • K-304
Eksperimentell: Elismetrep 20 mg

Participants received a single dose of elismetrep 20 mg
Legemiddel: Elismetrep

Administered orally

Andre navn:
  • K-304
Placebo komparator: Placebo

Participants received a single dose of placebo
Legemiddel: Placebo

Administered orally

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain freedom at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report no pain at 2 hours post-dose. Pain will be measured on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Two hours post-dose
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report absence of their MBS (nausea, phonophobia, or photophobia) at 2 hours post-dose. MBS will be measured using a binary scale (0=absent, 1=present).
Two hours post-dose

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Tidsramme: Up to 8 days post-dose
Up to 8 days post-dose
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Tidsramme: Up to 8 days post-dose
Up to 8 days post-dose
Pain relief at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 2 hours post-dose.
Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose
Tidsramme: From 2 to 24 hours post-dose

Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
From 2 to 24 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose

Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
From 2 to 48 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose
Tidsramme: From 2 to 24 hours post-dose

Percentage of subjects who do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
From 2 to 24 hours post-dose
Sustained pain relief from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose

Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
From 2 to 48 hours post-dose
Freedom from functional disability at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who self-report as being able to function normally on the functional disability scale in the subset of subjects who reported any level of disability at baseline. The scale has a 4-point numeric rating: normal (0); mildly impaired (1); moderately impaired (2); severely impaired, requires bedrest (3).
Two hours post-dose
Proportion requiring rescue medication within 24 hours post-dose
Tidsramme: Within 24 hours post-dose

Percentage of subjects that take rescue medication within 24 hours post-dose.
Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report the absence of photophobia at 2 hours post-dose in the subset of subjects who reported the presence of photophobia at baseline.
Two hours post-dose
Freedom from phonophobia at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report the absence of phonophobia at 2 hours post-dose in the subset of subjects who reported the presence of phonophobia at baseline.
Two hours post-dose
Freedom from nausea at 2 hours post-dose
Tidsramme: Two hours post-dose

Percentage of subjects who report the absence of nausea at 2 hours post-dose in the subset of subjects who reported the presence of nausea at baseline.
Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose

Percentage of subjects who are pain free at 2 hours post-dose and have (a) mild, moderate, or severe pain (response of 1, 2, or 3 on the 4-point Likert scale) at any time point after 2 hours post-dose, or (b) missing pain data at 24 hours or 48 hours after 2 hours post-dose, or (c) intervening rescue medication use at or before 48 hours post-dose.
From 2 to 48 hours post-dose

Samarbeidspartnere og etterforskere

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

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
TriGemX Bio, 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)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
2. oktober 2026

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
1. oktober 2027

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
1. desember 2027

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
7. september 2026

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
7. september 2026

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
11. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
11. november 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • K-304 P004

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. .

Innstillinger for informasjonskapsler

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