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New migraine pill shows promise in large trial

NCT ID NCT06603623

Symptom relief Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called BHV-2100 for quickly stopping migraine pain and related symptoms like nausea or sensitivity to light. About 647 people with migraines took either the drug or a placebo. The goal was to see if the drug could provide pain relief within 2 hours.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

647 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following: 1. 2-8 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period. 2. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period. 3. Participants on prophylactic migraine medication are permitted to remain on therapy they have been on a stable dose for at least 3 months prior to the Screening Visit. Key Exclusion Criteria: 1. Participants with a history of basilar migraine or hemiplegic migraine. 2. Participants who have taken medication for acute treatment of headache (including triptans, ergotamine, opioids, acetaminophen, NSAIDs, or combination analgesics) on 10 or more days in any of the 3 months prior to screening. 3. Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before screening. 4. History of chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.), or individuals who have received anti-HCV treatment within 6 months prior to Screening. 5. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. participants 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. 6. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however, participants can be included who have stable hypertension and/or stable diabetes for at least 3 months prior to being enrolled). A single blood pressure measurement of greater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest is exclusionary. 7. Participant has a current diagnosis of major depression, other pain syndromes (e.g. chronic pelvic pain, chronic regional pain syndrome, fibromyalgia), psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments. 8. Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption. 9. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers. 10. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • Accellacare of Raleigh

    Raleigh, North Carolina, 27609, United States

  • ActivMed Practices & Research-Portsmouth/Pease

    Portsmouth, New Hampshire, 03801, United States

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102, United States

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri, 64114, United States

  • AppleMed Research Group

    Miami, Florida, 33126, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Cenexel CIT IE

    Riverside, California, 92506, United States

  • Cenexel CNS Los Alamitos

    Los Alamitos, California, 90720, United States

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911, United States

  • Chicago Headache Center & Research Center

    Chicago, Illinois, 60657, United States

  • Clinical Research Institute

    Los Angeles, California, 90048, United States

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402, United States

  • Clinvest Research

    Springfield, Missouri, 65807, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Collective Medical Research

    Overland Park, Kansas, 66210, United States

  • Crescent City Headache & Neurology

    Chalmette, Louisiana, 70043, United States

  • DM Clinical Research - Belliare

    Houston, Texas, 77081, United States

  • DM Clinical Research - Tomball

    Tomball, Texas, 77375, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • Epic Clinical Research

    Lewisville, Texas, 75057, United States

  • Fieve Clinical Research, Inc.

    New York, New York, 10017, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78732, United States

  • Green Leaf Clinical Trials

    Jacksonville, Florida, 32258, United States

  • Hasbani Neurology

    New Haven, Connecticut, 06511, United States

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422, United States

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424, United States

  • Ideal Research

    Pembroke Pines, Florida, 33014, United States

  • Integrated Clinical Trials Services

    West Des Moines, Iowa, 50265, United States

  • KCA Neurology

    Franklin, Tennessee, 37067, United States

  • Ki Health Partners DBA/ New England Institute for Clinical Research

    Stamford, Connecticut, 06905, United States

  • L-MARC Research Center

    Louisville, Kentucky, 40213, United States

  • MD First Research

    Gilbert, Arizona, 85286, United States

  • Mass Institute of Clinical Research

    Westborough, Massachusetts, 01581, United States

  • MedVadis Research Corp

    Waltham, Massachusetts, 02451, United States

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48112, United States

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Neurology Center of New England PC

    Foxborough, Massachusetts, 02035, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034, United States

  • PharmQuest Life Sciences

    Greensboro, North Carolina, 27408, United States

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15410, United States

  • Premier Research Instiute

    West Palm Beach, Florida, 33407, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 47334, United States

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566, United States

  • Rochester Clinical Research

    Rochester, New York, 14609, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98104, United States

  • StudyMedrix Research

    City of Saint Peters, Missouri, 63303, United States

  • Velocity Clinical Research, Columbia

    Columbia, South Carolina, 29204, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research, Vestal

    Vestal, New York, 13850, United States

  • WR-CRNC (Wake Research)

    Las Vegas, Nevada, 89118, United States

  • WR-MSRA (Multi-Specialty Research Associates)

    Lake City, Florida, 32055, United States

  • WR-PRI, LLC (Encino)

    Encino, California, 91316, United States

  • WR-PRI, LLC (Newport Beach)

    Newport Beach, California, 92660, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.