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NCT07674654ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.
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In brief

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 sought113 sites1 country

Categories

Neurology100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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 (โ€”) means the record does not state something โ€” 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 sponsorโ€™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 ยท ruleset v1

Trial stature

Three independent measures of this study, described from its registry record โ€” 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 โ€” 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 โ€” 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.

Summary

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.

Conditions

  • Acute Migraine

Eligibility

SexAll
Ages18 Years โ€“ No maximum
Healthy volunteersNo

Eligibility as written in the registry

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. โ‰ค 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 3
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingTRIPLE (3)
Enrolment1,000 participants sought

Sponsor and collaborators

  • Kallyope Inc. Sponsor

Arms and interventions

  • Elismetrep 10 mgEXPERIMENTAL
  • Elismetrep 20 mgEXPERIMENTAL

Interventions

  • Drug Elismetrep

    Administered orally

  • Drug Placebo

    Administered orally

Outcome measures

  1. Primary outcome

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

    Time frame Through study completion, an average of 1 year

  2. Primary outcome

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

    Time frame Through study completion, an average of 1 year

  3. Primary outcome

    Proportion of participants with TEAEs leading to study drug discontinuation

    Time frame Through study completion, an average of 1 year

  4. Primary outcome

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

    Time frame Through study completion, an average of 1 year

Dates

Start dateAugust 3, 2026 (actual)
Primary completionJune 1, 2028 (estimated)
CompletionJune 1, 2028 (estimated)
First postedJune 29, 2026 (actual)
Last updatedAugust 27, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

113 sites are recruiting

United States

FacilityCityState or regionStatus
Albuquerque Clinical TrialsAlbuquerqueNew MexicoRecruiting
Lehigh Center for Clinical ResearchAllentownPennsylvaniaRecruiting
Dent Neuro Institute, BuffaloAmherstNew YorkRecruiting
Michigan Headache Pain & Neurological InstituteAnn ArborMichiganRecruiting
DelRicht ResearchAtlantaGeorgiaRecruiting
Tekton ResearchAustinTexasRecruiting
FutureSearch Trials of NeurologyAustinTexasRecruiting
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)BardstownKentuckyRecruiting
Central Research Associates, LLC (CRA) dba Flourish ResearchBirminghamAlabamaRecruiting
Boston Clinical Trials - AlcanzaBostonMassachusettsRecruiting
Pantheon Clinical ResearchBountifulUtahRecruiting
SPRI Clinical Trials, LLCBrooklynNew YorkRecruiting
IMMUNOe Research CentersCentennialColoradoRecruiting
Crescent City Headache & Neurology CenterChalmetteLouisianaRecruiting
TrialSphereChandlerArizonaRecruiting
OnSite Clinical SolutionsCharlotteNorth CarolinaRecruiting
WR-ClinSearch, LLCChattanoogaTennesseeRecruiting
Chicago Headache Center & Research InstituteChicagoIllinoisRecruiting
Cedar Crosse Research CenterChicagoIllinoisRecruiting
StudyMetrix ResearchCity of Saint PetersMissouriRecruiting
MCB Clinical Research CentersColorado SpringsColoradoRecruiting
Axiom Research, LLCColtonCaliforniaRecruiting
Hometown ResearchColumbusOhioRecruiting
True North NeurologyCommackNew YorkRecruiting
ProScience Research GroupCulver CityCaliforniaRecruiting
Horizon Clinical Research and Gill NeuroscienceCypressTexasRecruiting
APD Clinical ResearchCypressTexasRecruiting
FutureSearch Trials of Dallas, LPDallasTexasRecruiting
J. Lewis Research, Inc. / Foothill Family Clinic DraperDraperUtahRecruiting
OK Clinical Research, LLCEdmondOklahomaRecruiting
Leading Edge Research LA, LLCEncinoCaliforniaRecruiting
Healthcare Research Network II, LLCFlossmoorIllinoisRecruiting
Advanced Neurosciences ResearchFort CollinsColoradoRecruiting
Guilford Neurologic Research Partners, LLCGreensboroNorth CarolinaRecruiting
Headache Wellness CenterGreensboroNorth CarolinaRecruiting
DelRicht ResearchGulfportMississippiRecruiting
Healthcare Research NetworkHazelwoodMissouriRecruiting
DM Clinical ResearchHoustonTexasRecruiting
Victorium Clinical ResearchHoustonTexasRecruiting
Axiom Research, Orange CountyIrvineCaliforniaRecruiting
AMR Clinical - Kansas CityKansas CityMissouriRecruiting
Clinical Investigation Specialists, Inc.KenoshaWisconsinRecruiting
GMG Clinical Research, LLC dba Radiance Clinical ResearchLampasasTexasRecruiting
Wake Research Las Vegas RainbowLas VegasNevadaRecruiting
IMA Clinical Research - Las VegasLas VegasNevadaRecruiting
Excel Clinical ResearchLas VegasNevadaRecruiting
AMR Clinical - Las VegasLas VegasNevadaRecruiting
Redbird ResearchLas VegasNevadaRecruiting
CTI Clinical Research CenterLexingtonKentuckyRecruiting
AMR Clinical - LexingtonLexingtonKentuckyRecruiting

63 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 27, 2026

    Site removed

    1 site removed (113 total)

    114113

  2. August 6, 2026

    Status changed

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. August 6, 2026

    Recruitment opened

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. August 6, 2026

    Site removed

    1 site removed (114 total)

    115114

Registry: ClinicalTrials.gov ยท NCT########

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