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NCT07674654ClinicalTrials.gov

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

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En resumen

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.

Fase 31000 participantes buscados113 centros1 país

Categorías

Neurología100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Acute Migraine

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoTRIPLE (3)
Inscripción1000 participantes buscados

Patrocinador y colaboradores

  • Kallyope Inc. Patrocinador

Grupos e intervenciones

  • Elismetrep 10 mgEXPERIMENTAL
  • Elismetrep 20 mgEXPERIMENTAL

Intervenciones

  • Fármaco Elismetrep

    Administered orally

  • Fármaco Placebo

    Administered orally

Variables de resultado

  1. Variable de resultado principal

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

    Plazo Through study completion, an average of 1 year

  2. Variable de resultado principal

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

    Plazo Through study completion, an average of 1 year

  3. Variable de resultado principal

    Proportion of participants with TEAEs leading to study drug discontinuation

    Plazo Through study completion, an average of 1 year

  4. Variable de resultado principal

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

    Plazo Through study completion, an average of 1 year

Fechas

Fecha de inicio3 de agosto de 2026 (real)
Finalización principal1 de junio de 2028 (estimada)
Finalización1 de junio de 2028 (estimada)
Primera publicación29 de junio de 2026 (real)
Última actualización27 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

113 centros están en reclutamiento

United States

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

En el registro figuran 63 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 27 de agosto de 2026

    Centro eliminado

    1 site removed (113 total)

    114113

  2. 6 de agosto de 2026

    Estado modificado

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. 6 de agosto de 2026

    Reclutamiento abierto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. 6 de agosto de 2026

    Centro eliminado

    1 site removed (114 total)

    115114

Registro: ClinicalTrials.gov · NCT########

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