Phase
Condition
Oral Facial Pain
Migraine (Adult)
Migraine And Cluster Headaches
Treatment
Placebo
Elismetrep (K-304) Dose level 4
Elismetrep (K-304) Dose Level 1
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be a male or female, age 18 to 70 years, inclusive, at the time of signing informedconsent.
Patient has greater than a one-year history of migraine with or without aura asdefined by International Conference on Harmonization (IHS) criteria 1.1 and 1.2 andhis/her migraines typically last between 4 to 72 hours, if untreated as documentedin the patient's medical records from his/her treating physician and confirmed bythe investigator.
Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each ofthe two months prior to screening (Visit 1).
Meet the following requirements:
Is a male OR
Is a female who is of non-childbearing potential defined by at least 1 of thefollowing criteria:
Postmenopausal (aged >45 years and with a minimum of 12 months of spontaneousamenorrhea with a Screening serum follicle-stimulating hormone (FSH) level inthe menopausal range established for the central laboratory.
Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based onthe subject's recall of their medical history.OR
Is a female of reproductive potential and:
agrees to remain abstinent from heterosexual activity* *Abstinence can be used as the sole method of contraception if it is in linewith the subject's preferred and usual lifestyle and if considered acceptableby local regulatory agencies and ethics committees. Periodic abstinence (e.g.,calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) andwithdrawal are not acceptable methods of contraception.
or agrees to use (or have their partner use) a birth control method that isacceptable 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 contraceptionassociated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition ofovulation:
- 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 ofovulation 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 withspermicide (double barrier methods) This condition is waived if the subject is proven to have no child-bearing potential (eg, hysterectomy).
Patient voluntarily agrees to participate in the study by giving written informedconsent.
Patient is able to read, understand and complete the study questionnaires and diary.
Be willing and able to comply with the study schedule of visits, all trialprocedures and restrictions.
Be willing to use their own personal, qualified smartphone to download studyspecific eDiary applications for use during the study.
Exclusion
Exclusion Criteria:
Is a female who is pregnant, breast-feeding or intends to become pregnant during theplanned course of the study. Note: Participants must have a negative serum pregnancytest (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratoryprior to enrollment in the study and negative urine pregnancy result at therandomization visit. Migraine history-related
Patient has difficulty distinguishing his/her migraine attacks from tension-typeheadaches.
Patient has a history of predominantly mild migraine attacks or migraines thatusually resolve spontaneously in less than two hours.
Patient has more than 15 headache-days per month or has taken medication for acuteheadache on more than 10 days per month in any of the three months prior toscreening (Visit 1).
Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, orretinal migraine.
Patient was >50 years old at age of first migraine onset.
Patient is taking migraine prophylactic medication where the prescribed daily dosehas changed during the 3 months prior to screening (Visit 1) or anticipates anychange during the study. Any withdrawal of preventive medications for the treatmentof migraine should be completed at least 30 days prior to screening. Medical history related
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 whoare currently being treated with non-prohibited medication for depression andsymptoms are well controlled, in the opinion of the investigator, are eligible toparticipate in this study].
Patient is at imminent risk of self-harm, based on clinical interview and responseson the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others inthe opinion of the investigator. Patients must be excluded if they report suicidalideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) inthe past 2 months or suicidal behavior in the past 6 months.
Has a recent history (within the past 3 years of the screening visit) or currentdiagnosis or evidence of endocrine, hematological, immunological, renal,respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalitiesor diseases that, per the investigator's judgement, may jeopardize the subject'ssafety or compliance with the protocol, or otherwise interfere with interpretationof efficacy and/or safety results.
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 theyhave received treatment and follow-up consistent with local standard of care.
Patient history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), AcuteCoronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery,stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Has a history of human immunodeficiency virus disease.
Patient has a history of gastric or small intestinal surgery (including gastricbypass surgery or banding but not including cholecystectomy or appendectomy) or hasa disease that causes malabsorption. Laboratory, vital sign, and electrocardiogram (ECG) related
Has a positive test result at Screening for hepatitis B surface antigen (Ag),hepatitis C virus antibody.
Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with theModification of Diet in Renal Disease (MDRD) equation of <45 ml/min/1.73 m2.
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 atthe Screening visit. Note: An isolated bilirubin >1.5X ULN is acceptable ifbilirubin is fractionated, and direct bilirubin is within the laboratory normalrange.
Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec)for males and >470 msec for females at screening.
Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/ordiastolic blood pressure (BP) >95 mmHg measured after at least 5 minutes at rest atthe Screening Visit. Note: If a subject's BP is exclusionary on the first triplicate assessment at theScreening visit, they may have 1 repeat triplicate BP assessment at that visit afteranother rest of at least 10 minutes. Medication use and substance abuse related
Has known history of or suspected abuse of alcohol or recreational drugs atScreening.
Has use of soft drugs (such as marijuana or any substances containingtetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening,or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior toScreening.
Has a positive drug screen at Screening. Note: If benzodiazepines are detected onthe drug screen, this is not exclusionary if they are prescribed a benzodiazepinefor a therapeutic purpose (e.g. for insomnia) and confirmatory documentation isobtained from the prescribing physician.
Is currently in violation of study requirements for prohibited and permissibleconcomitant medications (not already specified in other criteria) or is anticipatedto violate these requirements during study participation.
Has any use of prescription opiate medications within 14 days of screening or anyanticipated/potential use of opiates during study participation.
History of use of ergotamine medications on greater than/equal 10 days per month ona regular basis for greater than/equal 3 months prior to screening.
History of non-narcotic analgesic intake on greater than/equal 15 days per month forgreater than/equal 3 months prior to screening. Other
Has known or suspected hypersensitivity to trial product(s) or related products.
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 toprescription or nonprescription drugs or food.
Has any surgery scheduled for the duration of the trial.
Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4weeks 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).
Has previous participation in this trial. Participation is defined as signedinformed consent.
Has participated in any clinical trial of an approved or non-approvedinvestigational biological medicinal product (e.g. antibody therapy) within 90 daysof Screening or has participated in any clinical trial of an approved ornon-approved investigational small molecule medicinal product within 30 days or 5half-lives (whichever is longer) of Screening.
Has any other disorder, unwillingness or inability, not covered by any of the otherexclusion criteria, which in the investigator's opinion, might jeopardize thesubject's safety or compliance with the protocol, or otherwise interfere withinterpretation of efficacy and/or safety results.
Is an employee or immediate family member (e.g., spouse, parent, child, sibling) ofthe Sponsor or study site.
Study Design
Connect with a study center
Central Research Associates, LLC (CRA) dba Flourish Research
Birmingham, Alabama 35205
United StatesActive - Recruiting
AMR Mobile
Mobile, Alabama 36608
United StatesActive - Recruiting
Wake Research/ Tucson Neuroscience Research
Tucson, Arizona 85710
United StatesActive - Recruiting
Hope Clinical Research
Canoga Park, California 91303
United StatesActive - Recruiting
WR-PRI, LLC (Encino)
Encino, California 91316
United StatesActive - Recruiting
Marvel Clinical Research
Huntington Beach, California 92647
United StatesActive - Recruiting
Eximia Research - CA
La Mesa, California 91942
United StatesActive - Recruiting
Synergy San Diego
Lemon Grove, California 91945
United StatesActive - Recruiting
WR-PRI, LLC (Newport Beach)
Newport Beach, California 92660
United StatesActive - Recruiting
Excell Research, Inc.
Oceanside, California 92056
United StatesActive - Recruiting
Empire Clinical Research
Pomona, California 91767
United StatesActive - Recruiting
Artemis Institute for Clinical Research - Riverside
Riverside, California 92503
United StatesActive - Recruiting
Acclaim Clinical Research
San Diego, California 89109
United StatesActive - Recruiting
Artemis Institute for Clinical Research - San Diego
San Diego, California 92103
United StatesActive - Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesActive - Recruiting
Focus Clinical Research
West Hills, California 91307
United StatesActive - Recruiting
CT Clinical Research
Cromwell, Connecticut 06416
United StatesActive - Recruiting
DelRicht Research
Atlanta, Georgia 30329
United StatesActive - Recruiting
Clinical Research Atlanta - Stockbridge
Stockbridge, Georgia 30281
United StatesActive - Recruiting
Northwest Clinical Trials
Boise, Idaho 83704
United StatesActive - Recruiting
Cedar Crosse Research Center
Chicago, Illinois 60607
United StatesActive - Recruiting
Healthcare Research Network II, LLC
Flossmoor, Illinois 60422
United StatesActive - Recruiting
Collective Medical Research
Overland Park, Kansas 66202
United StatesActive - Recruiting
Alliance for Multispecialty Research
Wichita, Kansas 67207
United StatesActive - Recruiting
L-MARC Research Center
Louisville, Kentucky 40213
United StatesActive - Recruiting
Crescent City Headache & Neurology Center
Chalmette, Louisiana 70043
United StatesActive - Recruiting
DelRicht Research
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104
United StatesActive - Recruiting
Clinical Research Institute
Minneapolis, Minnesota 55402
United StatesActive - Recruiting
DelRicht Research
Gulfport, Mississippi 39503
United StatesActive - Recruiting
Healthcare Research Network
Hazelwood, Missouri 63042
United StatesActive - Recruiting
Excel Clinical Research
Las Vegas, Nevada 89109
United StatesActive - Recruiting
Las Vegas Clinical Trials
North Las Vegas, Nevada 89119
United StatesActive - Recruiting
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Dent Neurosciences Research Center
Amherst, New York 14226
United StatesActive - Recruiting
CNY Clinical Research
Manlius, New York 13104
United StatesActive - Recruiting
Rochester Clinical Research
Rochester, New York 14609
United StatesActive - Recruiting
Upstate Clinical Research Associates LLC
Williamsville, New York 14221
United StatesActive - Recruiting
Headache Wellness Center
Greensboro, North Carolina 27405
United StatesActive - Recruiting
Peters Medical Research
High Point, North Carolina 27260
United StatesActive - Recruiting
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesActive - Recruiting
OK Clinical Research, LLC
Edmond, Oklahoma 73034
United StatesActive - Recruiting
Hightower Clinical
Oklahoma City, Oklahoma 73102
United StatesActive - Recruiting
DelRicht Research
Tulsa, Oklahoma 74133
United StatesActive - Recruiting
Tekton Research
Yukon, Oklahoma 73099
United StatesActive - Recruiting
Summit Research Network
Portland, Oregon 97210
United StatesActive - Recruiting
Lehigh Center for Clinical Research
Allentown, Pennsylvania 18103
United StatesActive - Recruiting
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Frontier Clinical Research, LLC
Scottdale, Pennsylvania 15683
United StatesActive - Recruiting
Frontier Clinical Research, LLC
Smithfield, Pennsylvania 15478
United StatesActive - Recruiting
Atlas-Clinical
West Chester, Pennsylvania 19380
United StatesActive - Recruiting
Clinical Trials of South Carolina
Charleston, South Carolina 29406
United StatesActive - Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina 29405
United StatesActive - Recruiting
WR-ClinSearch
Chattanooga, Tennessee 37421
United StatesActive - Recruiting
AMR Knoxville (Formerly NOCCR)
Knoxville, Tennessee 37909
United StatesActive - Recruiting
Clinical Research Associates, Inc.
Nashville, Tennessee 37203
United StatesActive - Recruiting
Donald J Garcia Jr, MD, PA
Austin, Texas 78737
United StatesActive - Recruiting
Tekton Research
Austin, Texas 78745
United StatesActive - Recruiting
FutureSearch Trials of Dallas, LP
Dallas, Texas 75251
United StatesActive - Recruiting
Victorium Clinical Research LTD CO
Houston, Texas 77024
United StatesActive - Recruiting
Clinical Trials of Texas, LLC, A Flourish Research Site
San Antonio, Texas 78229
United StatesSite Not Available
APD Clinical Research
Splendora, Texas 77372
United StatesActive - Recruiting
ClinPoint Trials
Waxahachie, Texas 75165
United StatesActive - Recruiting
Advanced Research Institute
Ogden, Utah 84405
United StatesActive - Recruiting
Health Research of Hampton Roads, Inc.
Newport News, Virginia 23606
United StatesActive - Recruiting
Frontier Clinical Research, LLC
Morgantown, West Virginia 26505
United StatesActive - Recruiting
Clinical Investigation Specialist
Kenosha, Wisconsin 53144
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.