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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Elismetrep 10 mg
  • Drug: Elismetrep
    Administered orally
    Other names:
    • K-304
  • Drug: Placebo
    Administered orally
Experimental
Elismetrep 20 mg
  • Drug: Elismetrep
    Administered orally
    Other names:
    • K-304

Recruiting Locations

Central Research Associates, LLC (CRA) dba Flourish Research
Birmingham, Alabama 35205

AMR Mobile
Mobile, Alabama 36608

TrialSphere
Chandler, Arizona 85286

Arkansas Clinical Research
Little Rock, Arkansas 72205

Axiom Research, LLC
Colton, California 92324

ProScience Research Group
Culver City, California 90230

Leading Edge Research LA, LLC
Encino, California 91316

Axiom Research, Orange County
Irvine, California 92604

Downtown L.A. Research Center, Inc.
Los Angeles, California 90017

Clinical Research Institute
Los Angeles, California 90048

M3 Wake Research - Mission Mental Health (WR-MMH)
Mission Viejo, California 92691

Excell Research
Oceanside, California 92056

Empire Clinical Research
Pomona, California 91767

The Neurology Group
Pomona, California 91767

Artemis Institute for Clinical Research
Riverside, California 92503

Acclaim Clinical Research
San Diego, California 92120

CenExel Sherman Oaks CA (California Neuroscience Research)
Sherman Oaks, California 91403

Encompass Clinical Research
Spring Valley, California 91978

Sunwise Clinical Research
Walnut Creek, California 94596

Diablo Clinical Research
Walnut Creek, California 94598

Kinetic Clinical Research
West Covina, California 91790

Focus Clinical Research
West Hills, California 91307

IMMUNOe Research Centers
Centennial, Colorado 80112

MCB Clinical Research Centers
Colorado Springs, Colorado 80910

Advanced Neurosciences Research
Fort Collins, Colorado 80528

Chase Medical Research, LLC
Waterbury, Connecticut 06708

DelRicht Research
Atlanta, Georgia 30329

Drug Studies America
Marietta, Georgia 30060

Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
Stockbridge, Georgia 30281

Cedar Crosse Research Center
Chicago, Illinois 60607

Chicago Headache Center & Research Institute
Chicago, Illinois 60657

Healthcare Research Network II, LLC
Flossmoor, Illinois 60447

Chicago Headache Center & Research Institute
Naperville, Illinois 60563

Integrated Clinical Trials Solution
West Des Moines, Iowa 50265

Collective Medical Research
Overland Park, Kansas 66212

Clinical Associates Midwest, LLC
Overland Park, Kansas 66214

Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas 67207

Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
Bardstown, Kentucky 40004

AMR Clinical - Lexington
Lexington, Kentucky 40509

CTI Clinical Research Center
Lexington, Kentucky 45212

Crescent City Headache & Neurology Center
Chalmette, Louisiana 70043

DelRicht Research
New Orleans, Louisiana 70115

Headlands Research - PharmaSite
Pikesville, Maryland 21208

Boston Clinical Trials - Alcanza
Boston, Massachusetts 02131

MedVadis Research Corporation, LLC
Waltham, Massachusetts 02451

Michigan Headache Pain & Neurological Institute
Ann Arbor, Michigan 48104

Clinical Research Institute
Minneapolis, Minnesota 55402

DelRicht Research
Gulfport, Mississippi 39503

Proven Endpoints
Ridgeland, Mississippi 39157

StudyMetrix Research
City of Saint Peters, Missouri 63303

Healthcare Research Network
Hazelwood, Missouri 63042

AMR Clinical - Kansas City
Kansas City, Missouri 64114

Clinvest Headlands LLC
Springfield, Missouri 65807

Sundance Clinical Research
St Louis, Missouri 63141

IMA Clinical Research - Las Vegas
Las Vegas, Nevada 89102

Excel Clinical Research
Las Vegas, Nevada 89109

Wake Research Las Vegas Rainbow
Las Vegas, Nevada 89118

AMR Clinical - Las Vegas
Las Vegas, Nevada 89119

Redbird Research
Las Vegas, Nevada 89119

Las Vegas Clinical Trials
North Las Vegas, Nevada 89030

Advanced Research Institute-Reno
Reno, Nevada 89511

Albuquerque Clinical Trials
Albuquerque, New Mexico 87102

Dent Neuro Institute, Buffalo
Amherst, New York 14226

SPRI Clinical Trials, LLC
Brooklyn, New York 11235

True North Neurology
Commack, New York 11725

Central New York Clinical Research
Manlius, New York 13104

Fieve Clinical Research, Inc
New York, New York 10017

Rochester Clinical Research
Rochester, New York 14609

Upstate Clinical Research Associates
Williamsville, New York 14221

OnSite Clinical Solutions
Charlotte, North Carolina 28277

Guilford Neurologic Research Partners, LLC
Greensboro, North Carolina 27405

Headache Wellness Center
Greensboro, North Carolina 27405

Eximia Research - NC, LLC
Raleigh, North Carolina 27607

Carolina Research Center, Inc
Shelby, North Carolina 28150

Hometown Research
Columbus, Ohio 43228

Hometown Research
Milford, Ohio 45150

CincyScience
West Chester, Ohio 45069

OK Clinical Research, LLC
Edmond, Oklahoma 73034

Hightower Clinical
Oklahoma City, Oklahoma 73102

DelRicht Research
Tulsa, Oklahoma 74133

Tekton Research, Inc.
Yukon, Oklahoma 73099

Summit Research Network
Portland, Oregon 97210

Advanced Research Institute-Portland
Portland, Oregon 97223

Lehigh Center for Clinical Research
Allentown, Pennsylvania 18103

Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114

Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania 15236

Frontier Clinical Research, LLC
Scottdale, Pennsylvania 15683

Frontier Clinical Research, LLC
Smithfield, Pennsylvania 15478

Coastal Carolina Research Center
North Charleston, South Carolina 29405

WR-ClinSearch, LLC
Chattanooga, Tennessee 37421

Access Clinical Trials Inc
Nashville, Tennessee 37203

Clinical Research Associates, Inc.
Nashville, Tennessee 37203

FutureSearch Trials of Neurology
Austin, Texas 78731

Tekton Research
Austin, Texas 78745

APD Clinical Research
Cypress, Texas 77372

Horizon Clinical Research and Gill Neuroscience
Cypress, Texas 77429

FutureSearch Trials of Dallas, LP
Dallas, Texas 75251

Victorium Clinical Research
Houston, Texas 77024

DM Clinical Research
Houston, Texas 77081

GMG Clinical Research, LLC dba Radiance Clinical Research
Lampasas, Texas 76550

Aim Trials, LLC
Plano, Texas 75093

ClinPoint Trials
Waxahachie, Texas 75165

Pantheon Clinical Research
Bountiful, Utah 84010

J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah 84020

Advanced Research Institute
Ogden, Utah 84405

Granger Medical Clinic
Riverton, Utah 84096

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84121

Health Research of Hampton Roads, Inc. (HRHR)
Newport News, Virginia 23606

AMR Clinical - Norfolk
Norfolk, Virginia 23502

Seattle Clinical Research Center
Seattle, Washington 98104

Frontier Clinical Research
Morgantown, West Virginia 26505

Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin 53144

More Details

Status
Recruiting
Sponsor
Kallyope Inc.

Study Contact

Annemarie Vance
917-336-3654
annemarie@kallyope.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.