COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine: A Range of Doses Will be Evaluated

Quick Facts

Study Start:2025-03-05

Study Completion:2025-08-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06848075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent. 2. Patient has greater than a one-year history of migraine with or without aura as defined by International Conference on Harmonization (IHS) 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 and confirmed by the investigator. 3. Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1). 4. Meet the following requirements: 1. Is a male OR 2. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria: 3. Postmenopausal (aged \>45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level in the menopausal range established for the central laboratory. 4. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history. 5. Is a female of reproductive potential and: 6. agrees to remain abstinent from heterosexual activity\* 7. or 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 trial (EoT) visit. Acceptable methods of birth control are: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal occlusion * vasectomised 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) 5. Patient voluntarily agrees to participate in the study by giving written informed consent. 6. Patient is able to read, understand and complete the study questionnaires and diary. 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.	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 serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit. 2. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches. 3. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours. 4. Patient 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 three months prior to screening (Visit 1). 5. Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine. 6. Patient was \>50 years old at age of first migraine onset. 7. Patient is taking migraine prophylactic medication where the prescribed daily 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. 8. Patient 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. Patient 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases 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. Patient 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 (MI), Acute Coronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening. 13. Has a history of human immunodeficiency virus disease. 14. Patient 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. 15. Has a positive test result at Screening for hepatitis B surface antigen (Ag), hepatitis C virus antibody. 16. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<45 ml/min/1.73 m2. 17. Has a screening result for alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range. 18. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening. 19. Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. 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: 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. 23. Is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria) or is anticipated to violate these requirements during study participation. 24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation. 25. History of use of ergotamine medications on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months prior to screening. 26. History of non-narcotic analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months prior to screening. 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. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit; 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. 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.

Inclusion Criteria

Exclusion Criteria

1. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent.
2. Patient has greater than a one-year history of migraine with or without aura as defined by International Conference on Harmonization (IHS) 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 and confirmed by the investigator.
3. Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1).
4. Meet the following requirements:
1. Is a male OR
2. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
3. Postmenopausal (aged \>45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level in the menopausal range established for the central laboratory.
4. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.
5. Is a female of reproductive potential and:
6. agrees to remain abstinent from heterosexual activity\*
7. or 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 trial (EoT) visit. Acceptable methods of birth control are:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
* oral
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation:
* oral
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal occlusion
* vasectomised 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)
5. Patient voluntarily agrees to participate in the study by giving written informed consent.
6. Patient is able to read, understand and complete the study questionnaires and diary.
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.

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 serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
2. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches.
3. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
4. Patient 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 three months prior to screening (Visit 1).
5. Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine.
6. Patient was \>50 years old at age of first migraine onset.
7. Patient is taking migraine prophylactic medication where the prescribed daily 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.
8. Patient 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. Patient 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases 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. Patient 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 (MI), Acute Coronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
13. Has a history of human immunodeficiency virus disease.
14. Patient 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.
15. Has a positive test result at Screening for hepatitis B surface antigen (Ag), hepatitis C virus antibody.
16. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<45 ml/min/1.73 m2.
17. Has a screening result for alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range.
18. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening.
19. Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit.
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: 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.
23. Is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria) or is anticipated to violate these requirements during study participation.
24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
25. History of use of ergotamine medications on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months prior to screening.
26. History of non-narcotic analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months prior to screening.
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. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit; 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.
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.

Contacts and Locations

Study Locations (Sites)

Central Research Associates, LLC (CRA) dba Flourish Research

Birmingham, Alabama, 35205

United States

AMR Mobile

Mobile, Alabama, 36608

United States

Wake Research/ Tucson Neuroscience Research

Tucson, Arizona, 85710

United States

Hope Clinical Research

Canoga Park, California, 91303

United States

WR-PRI, LLC (Encino)

Encino, California, 91316

United States

Marvel Clinical Research

Huntington Beach, California, 92647

United States

Eximia Research - CA

La Mesa, California, 91942

United States

Synergy San Diego

Lemon Grove, California, 91945

United States

WR-PRI, LLC (Newport Beach)

Newport Beach, California, 92660

United States

Excell Research, Inc.

Oceanside, California, 92056

United States

Empire Clinical Research

Pomona, California, 91767

United States

Artemis Institute for Clinical Research - Riverside

Riverside, California, 92503

United States

Acclaim Clinical Research

San Diego, California, 89109

United States

Artemis Institute for Clinical Research - San Diego

San Diego, California, 92103

United States

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598

United States

Focus Clinical Research

West Hills, California, 91307

United States

CT Clinical Research

Cromwell, Connecticut, 06416

United States

DelRicht Research

Atlanta, Georgia, 30329

United States

Clinical Research Atlanta - Stockbridge

Stockbridge, Georgia, 30281

United States

Northwest Clinical Trials

Boise, Idaho, 83704

United States

Cedar Crosse Research Center

Chicago, Illinois, 60607

United States

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422

United States

Collective Medical Research

Overland Park, Kansas, 66202

United States

Alliance for Multispecialty Research

Wichita, Kansas, 67207

United States

L-MARC Research Center

Louisville, Kentucky, 40213

United States

Crescent City Headache & Neurology Center

Chalmette, Louisiana, 70043

United States

DelRicht Research

New Orleans, Louisiana, 70115

United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104

United States

Clinical Research Institute

Minneapolis, Minnesota, 55402

United States

DelRicht Research

Gulfport, Mississippi, 39503

United States

Healthcare Research Network

Hazelwood, Missouri, 63042

United States

Excel Clinical Research

Las Vegas, Nevada, 89109

United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89119

United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102

United States

Dent Neurosciences Research Center

Amherst, New York, 14226

United States

CNY Clinical Research

Manlius, New York, 13104

United States

Rochester Clinical Research

Rochester, New York, 14609

United States

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221

United States

Headache Wellness Center

Greensboro, North Carolina, 27405

United States

Peters Medical Research

High Point, North Carolina, 27260

United States

CTI Clinical Research Center

Cincinnati, Ohio, 45212

United States

OK Clinical Research, LLC

Edmond, Oklahoma, 73034

United States

Hightower Clinical

Oklahoma City, Oklahoma, 73102

United States

DelRicht Research

Tulsa, Oklahoma, 74133

United States

Tekton Research

Yukon, Oklahoma, 73099

United States

Summit Research Network

Portland, Oregon, 97210

United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103

United States

Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, 19114

United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683

United States

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478

United States

Atlas-Clinical

West Chester, Pennsylvania, 19380

United States

Clinical Trials of South Carolina

Charleston, South Carolina, 29406

United States

Coastal Carolina Research Center

North Charleston, South Carolina, 29405

United States

WR-ClinSearch

Chattanooga, Tennessee, 37421

United States

AMR Knoxville (Formerly NOCCR)

Knoxville, Tennessee, 37909

United States

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203

United States

Donald J Garcia Jr, MD, PA

Austin, Texas, 78737

United States

Tekton Research

Austin, Texas, 78745

United States

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251

United States

Victorium Clinical Research LTD CO

Houston, Texas, 77024

United States

APD Clinical Research

Splendora, Texas, 77372

United States

ClinPoint Trials

Waxahachie, Texas, 75165

United States

Advanced Research Institute

Ogden, Utah, 84405

United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606

United States

Frontier Clinical Research, LLC

Morgantown, West Virginia, 26505

United States

Clinical Investigation Specialist

Kenosha, Wisconsin, 53144

United States

Collaborators and Investigators

Sponsor: Kallyope Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05

Study Completion Date2025-08-11

Study Record Updates

Study Start Date2025-03-05

Study Completion Date2025-08-11

Terms related to this study

Additional Relevant MeSH Terms

Acute Migraine