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NCT07674654ClinicalTrials.gov

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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.

Phase 31 000 participants recherchés113 sites1 pays

Catégories

Neurologie100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-06-29; recorded start 2026-08-03
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Kallyope Inc.)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding16/20

    Triple-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 115 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 113 sites.

How this score is built
  • Enrolment30/40

    1,000 participants (target)

  • Site count23/25

    115 sites

  • Country count7/15

    2 countries

  • Planned duration7/10

    Planned over about 23 months

  • Sponsor scale2/10

    Kallyope Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

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.

Affections

  • Acute Migraine

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuTRIPLE (3)
Recrutement1 000 participants recherchés

Promoteur et collaborateurs

  • Kallyope Inc. Promoteur

Groupes et interventions

  • Elismetrep 10 mgEXPERIMENTAL
  • Elismetrep 20 mgEXPERIMENTAL

Interventions

  • Médicament Elismetrep

    Administered orally

  • Médicament Placebo

    Administered orally

Critères de jugement

  1. Critère de jugement principal

    Proportion of participants with at least one treatment-emergent adverse event (TEAE)

    Délai Through study completion, an average of 1 year

  2. Critère de jugement principal

    Proportion of participants with at least one treatment-emergent serious adverse event (SAE)

    Délai Through study completion, an average of 1 year

  3. Critère de jugement principal

    Proportion of participants with TEAEs leading to study drug discontinuation

    Délai Through study completion, an average of 1 year

  4. Critère de jugement principal

    Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm

    Délai Through study completion, an average of 1 year

Dates

Date de début3 août 2026 (réelle)
Achèvement principal1 juin 2028 (estimée)
Achèvement1 juin 2028 (estimée)
Première publication29 juin 2026 (réelle)
Dernière mise à jour27 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

113 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Albuquerque Clinical TrialsAlbuquerqueNew MexicoEn recrutement
Lehigh Center for Clinical ResearchAllentownPennsylvaniaEn recrutement
Dent Neuro Institute, BuffaloAmherstNew YorkEn recrutement
Michigan Headache Pain & Neurological InstituteAnn ArborMichiganEn recrutement
DelRicht ResearchAtlantaGeorgiaEn recrutement
Tekton ResearchAustinTexasEn recrutement
FutureSearch Trials of NeurologyAustinTexasEn recrutement
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)BardstownKentuckyEn recrutement
Central Research Associates, LLC (CRA) dba Flourish ResearchBirminghamAlabamaEn recrutement
Boston Clinical Trials - AlcanzaBostonMassachusettsEn recrutement
Pantheon Clinical ResearchBountifulUtahEn recrutement
SPRI Clinical Trials, LLCBrooklynNew YorkEn recrutement
IMMUNOe Research CentersCentennialColoradoEn recrutement
Crescent City Headache & Neurology CenterChalmetteLouisianaEn recrutement
TrialSphereChandlerArizonaEn recrutement
OnSite Clinical SolutionsCharlotteNorth CarolinaEn recrutement
WR-ClinSearch, LLCChattanoogaTennesseeEn recrutement
Chicago Headache Center & Research InstituteChicagoIllinoisEn recrutement
Cedar Crosse Research CenterChicagoIllinoisEn recrutement
StudyMetrix ResearchCity of Saint PetersMissouriEn recrutement
MCB Clinical Research CentersColorado SpringsColoradoEn recrutement
Axiom Research, LLCColtonCaliforniaEn recrutement
Hometown ResearchColumbusOhioEn recrutement
True North NeurologyCommackNew YorkEn recrutement
ProScience Research GroupCulver CityCaliforniaEn recrutement
Horizon Clinical Research and Gill NeuroscienceCypressTexasEn recrutement
APD Clinical ResearchCypressTexasEn recrutement
FutureSearch Trials of Dallas, LPDallasTexasEn recrutement
J. Lewis Research, Inc. / Foothill Family Clinic DraperDraperUtahEn recrutement
OK Clinical Research, LLCEdmondOklahomaEn recrutement
Leading Edge Research LA, LLCEncinoCaliforniaEn recrutement
Healthcare Research Network II, LLCFlossmoorIllinoisEn recrutement
Advanced Neurosciences ResearchFort CollinsColoradoEn recrutement
Guilford Neurologic Research Partners, LLCGreensboroNorth CarolinaEn recrutement
Headache Wellness CenterGreensboroNorth CarolinaEn recrutement
DelRicht ResearchGulfportMississippiEn recrutement
Healthcare Research NetworkHazelwoodMissouriEn recrutement
DM Clinical ResearchHoustonTexasEn recrutement
Victorium Clinical ResearchHoustonTexasEn recrutement
Axiom Research, Orange CountyIrvineCaliforniaEn recrutement
AMR Clinical - Kansas CityKansas CityMissouriEn recrutement
Clinical Investigation Specialists, Inc.KenoshaWisconsinEn recrutement
GMG Clinical Research, LLC dba Radiance Clinical ResearchLampasasTexasEn recrutement
Wake Research Las Vegas RainbowLas VegasNevadaEn recrutement
IMA Clinical Research - Las VegasLas VegasNevadaEn recrutement
Excel Clinical ResearchLas VegasNevadaEn recrutement
AMR Clinical - Las VegasLas VegasNevadaEn recrutement
Redbird ResearchLas VegasNevadaEn recrutement
CTI Clinical Research CenterLexingtonKentuckyEn recrutement
AMR Clinical - LexingtonLexingtonKentuckyEn recrutement

63 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 27 août 2026

    Site retiré

    1 site removed (113 total)

    114113

  2. 6 août 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. 6 août 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. 6 août 2026

    Site retiré

    1 site removed (114 total)

    115114

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07674654