NCT07645924ClinicalTrials.gov

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

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

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Contatta questo studio

In breve

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

Fase 31800 partecipanti ricercati113 centri1 paese

Categorie

Neurologia100%

Registrato in 1 registro

ClinicalTrials.govNCT07645924Apri questa scheda su ClinicalTrials.govSincronizzato mese scorso

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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.

Present: Registered before enrolment beganFirst posted 2026-06-12; recorded start 2026-07-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Kallyope Inc.)
Present: 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 arm13/15
Placebo / sham control arm
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: 1,800 participants (target), run at 113 sites.

How this score is built

Enrolment32/40
1,800 participants (target)
Site count23/25
115 sites
Country count7/15
2 countries
Planned duration3/10
Planned over about 7 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.

Sintesi

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

Patologie

Migraine

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – 75 Years
Volontari sani	No

Idoneità come riportata nel registro

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. 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 participant'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; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). 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: Participants 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 trial. 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 or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility). 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). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary: 1. Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache) 2. Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache). 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 P004. 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 participant'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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	TRIPLE (3)
Arruolamento	1800 partecipanti ricercati

Sponsor e collaboratori

Kallyope Inc. Sponsor

Bracci e interventi

Elismetrep 10 mgEXPERIMENTAL
Elismetrep 20 mgEXPERIMENTAL
PlaceboPLACEBO_COMPARATOR

Interventi

Farmaco Elismetrep
Administered orally
Farmaco Placebo
Administered orally

Esiti misurati

Esito primario
Pain freedom at 2 hours post-dose
Percentage of participants that 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).
Orizzonte temporale Two hours post-dose
Esito primario
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Percentage of participants that 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).
Orizzonte temporale Two hours post-dose
Esito secondario
Pain relief at 2 hours post-dose
Percentage of participants that 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.
Orizzonte temporale Two hours post-dose
Esito secondario
Sustained pain freedom from 2 to 48 hours post-dose
Percentage of participants that 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 48hours post-dose.
Orizzonte temporale From 2 to 48 hours post-dose
Esito secondario
Freedom from functional disability at 2 hours post-dose
Percentage of participants that self-report as being able to function normally on the functional disability scale in the subset of participants that 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).
Orizzonte temporale Two hours post-dose
Esito secondario
Pain relief at 60 minutes post-dose
Percentage of participants that 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 60 minutes post-dose
Orizzonte temporale Sixty minutes post-dose
Esito secondario
Proportion requiring rescue medication within 24 hours post-dose
Percentage of participants that take rescue medication within 24 hours post-dose.
Orizzonte temporale Within 24 hours post-dose
Esito secondario
Freedom from photophobia at 2 hours post-dose
Percentage of participants that report the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.
Orizzonte temporale Two hours post-dose
Esito secondario
Freedom from phonophobia at 2 hours post-dose
Percentage of participants that report the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.
Orizzonte temporale Two hours post-dose
Esito secondario
Freedom from nausea at 2 hours post-dose
Percentage of participants that report the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.
Orizzonte temporale Two hours post-dose
Esito secondario
Sustained pain freedom from 2 to 24 hours post-dose
Percentage of participants that 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.
Orizzonte temporale From 2 to 24 hours post-dose
Esito secondario
Sustained pain relief 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.
Orizzonte temporale From 2 to 48 hours post-dose
Esito secondario
Sustained pain relief from 2 to 24 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 or 24 hours post-dose.
Orizzonte temporale From 2 to 24 hours post-dose
Esito secondario
Pain relapse from 2 to 48 hours post-dose
Percentage of participants that 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.
Orizzonte temporale From 2 to 48 hours post-dose
Esito secondario
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Orizzonte temporale Up to 8 days post-dose
Esito secondario
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Orizzonte temporale Up to 8 days post-dose

Date

Date
Data di inizio	1 luglio 2026 (effettiva)
Conclusione primaria	1 febbraio 2027 (stimata)
Conclusione	1 febbraio 2027 (stimata)
Prima pubblicazione	12 giugno 2026 (effettiva)
Ultimo aggiornamento	20 agosto 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	agosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

113 centri stanno reclutando

United States

United States
Struttura	Città	Stato o regione	Stato
Albuquerque Clinical Trials	Albuquerque	New Mexico	In reclutamento
Lehigh Center for Clinical Research	Allentown	Pennsylvania	In reclutamento
Dent Neuro Institute, Buffalo	Amherst	New York	In reclutamento
Michigan Headache Pain & Neurological Institute	Ann Arbor	Michigan	In reclutamento
DelRicht Research	Atlanta	Georgia	In reclutamento
Tekton Research	Austin	Texas	In reclutamento
FutureSearch Trials of Neurology	Austin	Texas	In reclutamento
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)	Bardstown	Kentucky	In reclutamento
Central Research Associates, LLC (CRA) dba Flourish Research	Birmingham	Alabama	In reclutamento
Boston Clinical Trials - Alcanza	Boston	Massachusetts	In reclutamento
Pantheon Clinical Research	Bountiful	Utah	In reclutamento
SPRI Clinical Trials, LLC	Brooklyn	New York	In reclutamento
IMMUNOe Research Centers	Centennial	Colorado	In reclutamento
Crescent City Headache & Neurology Center	Chalmette	Louisiana	In reclutamento
TrialSphere	Chandler	Arizona	In reclutamento
OnSite Clinical Solutions	Charlotte	North Carolina	In reclutamento
WR-ClinSearch, LLC	Chattanooga	Tennessee	In reclutamento
Chicago Headache Center & Research Institute	Chicago	Illinois	In reclutamento
Cedar Crosse Research Center	Chicago	Illinois	In reclutamento
StudyMetrix Research	City of Saint Peters	Missouri	In reclutamento
MCB Clinical Research Centers	Colorado Springs	Colorado	In reclutamento
Axiom Research, LLC	Colton	California	In reclutamento
Hometown Research	Columbus	Ohio	In reclutamento
True North Neurology	Commack	New York	In reclutamento
ProScience Research Group	Culver City	California	In reclutamento
Horizon Clinical Research and Gill Neuroscience	Cypress	Texas	In reclutamento
APD Clinical Research	Cypress	Texas	In reclutamento
FutureSearch Trials of Dallas, LP	Dallas	Texas	In reclutamento
J. Lewis Research, Inc. / Foothill Family Clinic Draper	Draper	Utah	In reclutamento
OK Clinical Research, LLC	Edmond	Oklahoma	In reclutamento
Leading Edge Research LA, LLC	Encino	California	In reclutamento
Healthcare Research Network II, LLC	Flossmoor	Illinois	In reclutamento
Advanced Neurosciences Research	Fort Collins	Colorado	In reclutamento
Guildford Neurologic Research Partners, LLC	Greensboro	North Carolina	In reclutamento
Headache Wellness Center	Greensboro	North Carolina	In reclutamento
DelRicht Research	Gulfport	Mississippi	In reclutamento
Healthcare Research Network	Hazelwood	Missouri	In reclutamento
DM Clinical Research	Houston	Texas	In reclutamento
Victorium Clinical Research	Houston	Texas	In reclutamento
Axiom Research, Orange County	Irvine	California	In reclutamento
AMR Clinical - Kansas City	Kansas City	Missouri	In reclutamento
Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin	In reclutamento
GMG Clinical Research, LLC dba Radiance Clinical Research	Lampasas	Texas	In reclutamento
Wake Research Las Vegas Rainbow	Las Vegas	Nevada	In reclutamento
IMA Clinical Research - Las Vegas	Las Vegas	Nevada	In reclutamento
Excel Clinical Research	Las Vegas	Nevada	In reclutamento
AMR Clinical - Las Vegas	Las Vegas	Nevada	In reclutamento
Redbird Research	Las Vegas	Nevada	In reclutamento
CTI Clinical Research Center	Lexington	Kentucky	In reclutamento
AMR Clinical - Lexington	Lexington	Kentucky	In reclutamento

Nella scheda del registro sono indicati altri 63 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

20 agosto 2026
Centro rimosso
1 site removed (113 total)
114113
5 agosto 2026
Centro rimosso
1 site removed (114 total)
115114

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

https://xmedica.io/trials/ctgov/NCT07645924