A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at the long-term safety of elismetrep (K-304) and how well people handle it when used as needed for migraine attacks. It is for people who completed an earlier elismetrep migraine study and meet the study rules.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Complete the earlier study, K-304 P003, and attend its final visit within the allowed time. You must have treated a migraine that met that study’s rules.
- Complete at least 80% of daily electronic diary check-ins in the earlier study, plus the checks 2 and 4 hours after taking the drug.
- If you treated your migraine within 5 days of being assigned to a study group, you may have missed one daily check-in even if your rate was below 80%.
- Choose to join and sign a consent form.
- Be able to read, understand, and fill out the study forms and diary.
- Be willing and able to follow the visit schedule, study steps, and restrictions.
- Use your own smartphone that meets study needs, and download and use the diary apps throughout the study.
- If you can become pregnant, use a study-approved birth control method or avoid sex with men from the first dose through the final visit. Tracking fertile days or using withdrawal does not count.
Who can't join
- You are pregnant, breastfeeding, or plan to become pregnant during the study. A urine pregnancy test must be negative at the earlier study’s final visit.
- You have a new health change or lab result that the study doctor thinks makes the study unsuitable for you.
- You are at immediate risk of harming yourself or others, or report thoughts of suicide with intent to act, with or without a plan.
- You are not following, or are expected not to follow, the study’s rules about other medicines or treatments.
- You have major surgery planned during the study.
- The study doctor thinks another reason you cannot or will not follow study rules could affect your safety or the study results.
- You still have a health problem reported as an adverse event from the earlier study at Visit 1, or you had a serious adverse event in that study.
- You have already joined this study by signing its consent form after finishing the earlier study’s final visit steps.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (113)
AL
- Central Research Associates, LLC (CRA) dba Flourish Research · Birmingham, AL 35205More trials in Birmingham
- AMR Mobile · Mobile, AL 36608More trials in Mobile
AR
- Arkansas Clinical Research · Little Rock, AR 72205More trials in Little Rock
AZ
- TrialSphere · Chandler, AZ 85286More trials in Chandler
CA
- Axiom Research, LLC · Colton, CA 92324More trials in Colton
- ProScience Research Group · Culver City, CA 90230More trials in Culver City
- Leading Edge Research LA, LLC · Encino, CA 91316More trials in Encino
- Axiom Research, Orange County · Irvine, CA 92604More trials in Irvine
- Downtown L.A. Research Center, Inc. · Los Angeles, CA 90017More trials in Los Angeles
- Clinical Research Institute · Los Angeles, CA 90048More trials in Los Angeles
- M3 Wake Research - Mission Mental Health (WR-MMH) · Mission Viejo, CA 92691More trials in Mission Viejo
- Excell Research · Oceanside, CA 92056More trials in Oceanside
- Empire Clinical Research · Pomona, CA 91767More trials in Pomona
- The Neurology Group · Pomona, CA 91767More trials in Pomona
- Artemis Institute for Clinical Research · Riverside, CA 92503More trials in Riverside
- Acclaim Clinical Research · San Diego, CA 92120More trials in San Diego
- CenExel Sherman Oaks CA (California Neuroscience Research) · Sherman Oaks, CA 91403More trials in Sherman Oaks
- Encompass Clinical Research · Spring Valley, CA 91978More trials in Spring Valley
- Sunwise Clinical Research · Walnut Creek, CA 94596More trials in Walnut Creek
- Diablo Clinical Research · Walnut Creek, CA 94598More trials in Walnut Creek
- Kinetic Clinical Research · West Covina, CA 91790More trials in West Covina
- Focus Clinical Research · West Hills, CA 91307More trials in West Hills
CO
- IMMUNOe Research Centers · Centennial, CO 80112More trials in Centennial
- MCB Clinical Research Centers · Colorado Springs, CO 80910More trials in Colorado Springs
- Advanced Neurosciences Research · Fort Collins, CO 80528More trials in Fort Collins
CT
- Chase Medical Research, LLC · Waterbury, CT 06708More trials in Waterbury
GA
- DelRicht Research · Atlanta, GA 30329More trials in Atlanta
- Drug Studies America · Marietta, GA 30060More trials in Marietta
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge · Stockbridge, GA 30281More trials in Stockbridge
IA
- Integrated Clinical Trials Solution · West Des Moines, IA 50265More trials in West Des Moines
IL
- Cedar Crosse Research Center · Chicago, IL 60607More trials in Chicago
- Chicago Headache Center & Research Institute · Chicago, IL 60657More trials in Chicago
- Healthcare Research Network II, LLC · Flossmoor, IL 60447More trials in Flossmoor
- Chicago Headache Center & Research Institute · Naperville, IL 60563More trials in Naperville
KS
- Collective Medical Research · Overland Park, KS 66212More trials in Overland Park
- Clinical Associates Midwest, LLC · Overland Park, KS 66214More trials in Overland Park
- Heartland Research Associates, LLC - An AMR Company · Wichita, KS 67207More trials in Wichita
KY
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research) · Bardstown, KY 40004More trials in Bardstown
- AMR Clinical - Lexington · Lexington, KY 40509More trials in Lexington
- CTI Clinical Research Center · Lexington, KY 45212More trials in Lexington
LA
- Crescent City Headache & Neurology Center · Chalmette, LA 70043More trials in Chalmette
- DelRicht Research · New Orleans, LA 70115More trials in New Orleans
MA
- Boston Clinical Trials - Alcanza · Boston, MA 02131More trials in Boston
- MedVadis Research Corporation, LLC · Waltham, MA 02451More trials in Waltham
MD
- Headlands Research - PharmaSite · Pikesville, MD 21208More trials in Pikesville
MI
- Michigan Headache Pain & Neurological Institute · Ann Arbor, MI 48104More trials in Ann Arbor
MN
- Clinical Research Institute · Minneapolis, MN 55402More trials in Minneapolis
MO
- StudyMetrix Research · City of Saint Peters, MO 63303More trials in City of Saint Peters
- Healthcare Research Network · Hazelwood, MO 63042More trials in Hazelwood
- AMR Clinical - Kansas City · Kansas City, MO 64114More trials in Kansas City
- Clinvest Headlands LLC · Springfield, MO 65807More trials in Springfield
- Sundance Clinical Research · St Louis, MO 63141More trials in St Louis
MS
- DelRicht Research · Gulfport, MS 39503More trials in Gulfport
- Proven Endpoints · Ridgeland, MS 39157More trials in Ridgeland
NC
- OnSite Clinical Solutions · Charlotte, NC 28277More trials in Charlotte
- Guilford Neurologic Research Partners, LLC · Greensboro, NC 27405More trials in Greensboro
- Headache Wellness Center · Greensboro, NC 27405More trials in Greensboro
- Eximia Research - NC, LLC · Raleigh, NC 27607More trials in Raleigh
- Carolina Research Center, Inc · Shelby, NC 28150More trials in Shelby
NM
- Albuquerque Clinical Trials · Albuquerque, NM 87102More trials in Albuquerque
NV
- IMA Clinical Research - Las Vegas · Las Vegas, NV 89102More trials in Las Vegas
- Excel Clinical Research · Las Vegas, NV 89109More trials in Las Vegas
- Wake Research Las Vegas Rainbow · Las Vegas, NV 89118More trials in Las Vegas
- AMR Clinical - Las Vegas · Las Vegas, NV 89119More trials in Las Vegas
- Redbird Research · Las Vegas, NV 89119More trials in Las Vegas
- Las Vegas Clinical Trials · North Las Vegas, NV 89030More trials in North Las Vegas
- Advanced Research Institute-Reno · Reno, NV 89511More trials in Reno
NY
- Dent Neuro Institute, Buffalo · Amherst, NY 14226More trials in Amherst
- SPRI Clinical Trials, LLC · Brooklyn, NY 11235More trials in Brooklyn
- True North Neurology · Commack, NY 11725More trials in Commack
- Central New York Clinical Research · Manlius, NY 13104More trials in Manlius
- Fieve Clinical Research, Inc · New York, NY 10017More trials in New York
- Rochester Clinical Research · Rochester, NY 14609More trials in Rochester
- Upstate Clinical Research Associates · Williamsville, NY 14221More trials in Williamsville
OH
- Hometown Research · Columbus, OH 43228More trials in Columbus
- Hometown Research · Milford, OH 45150More trials in Milford
- CincyScience · West Chester, OH 45069More trials in West Chester
OK
- OK Clinical Research, LLC · Edmond, OK 73034More trials in Edmond
- Hightower Clinical · Oklahoma City, OK 73102More trials in Oklahoma City
- DelRicht Research · Tulsa, OK 74133More trials in Tulsa
- Tekton Research, Inc. · Yukon, OK 73099More trials in Yukon
OR
- Summit Research Network · Portland, OR 97210More trials in Portland
- Advanced Research Institute-Portland · Portland, OR 97223More trials in Portland
PA
- Lehigh Center for Clinical Research · Allentown, PA 18103More trials in Allentown
- Clinical Research Philadelphia · Philadelphia, PA 19114More trials in Philadelphia
- Preferred Primary Care Physicians, Inc. · Pittsburgh, PA 15236More trials in Pittsburgh
- Frontier Clinical Research, LLC · Scottdale, PA 15683More trials in Scottdale
- Frontier Clinical Research, LLC · Smithfield, PA 15478More trials in Smithfield
SC
- Coastal Carolina Research Center · North Charleston, SC 29405More trials in North Charleston
TN
- WR-ClinSearch, LLC · Chattanooga, TN 37421More trials in Chattanooga
- Access Clinical Trials Inc · Nashville, TN 37203More trials in Nashville
- Clinical Research Associates, Inc. · Nashville, TN 37203More trials in Nashville
TX
- FutureSearch Trials of Neurology · Austin, TX 78731More trials in Austin
- Tekton Research · Austin, TX 78745More trials in Austin
- APD Clinical Research · Cypress, TX 77372More trials in Cypress
- Horizon Clinical Research and Gill Neuroscience · Cypress, TX 77429More trials in Cypress
- FutureSearch Trials of Dallas, LP · Dallas, TX 75251More trials in Dallas
- Victorium Clinical Research · Houston, TX 77024More trials in Houston
- DM Clinical Research · Houston, TX 77081More trials in Houston
- GMG Clinical Research, LLC dba Radiance Clinical Research · Lampasas, TX 76550More trials in Lampasas
- Aim Trials, LLC · Plano, TX 75093More trials in Plano
- ClinPoint Trials · Waxahachie, TX 75165More trials in Waxahachie
UT
- Pantheon Clinical Research · Bountiful, UT 84010More trials in Bountiful
- J. Lewis Research, Inc. / Foothill Family Clinic Draper · Draper, UT 84020More trials in Draper
- Advanced Research Institute · Ogden, UT 84405More trials in Ogden
- Granger Medical Clinic · Riverton, UT 84096More trials in Riverton
- J. Lewis Research, Inc. / Foothill Family Clinic · Salt Lake City, UT 84109More trials in Salt Lake City
- J. Lewis Research, Inc. / Foothill Family Clinic · Salt Lake City, UT 84121More trials in Salt Lake City
VA
- Health Research of Hampton Roads, Inc. (HRHR) · Newport News, VA 23606More trials in Newport News
- AMR Clinical - Norfolk · Norfolk, VA 23502More trials in Norfolk
WA
- Seattle Clinical Research Center · Seattle, WA 98104More trials in Seattle
WI
- Clinical Investigation Specialists, Inc. · Kenosha, WI 53144More trials in Kenosha
WV
- Frontier Clinical Research · Morgantown, WV 26505More trials in Morgantown