Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

NCT06603623 | Completed Phase 2 FDA Drug

• 1 other identifier: BHV2100-201
• Study Type: interventional
• Target: 647
• Locations: 1 country
• Sites: 60

Brief Summary

This study is designed to identify at least one dose of BHV-2100 that is safe and effective in reducing headache pain and other symptoms in the treatment of migraine.

Conditions

Migraine

Keywords

Acute Migraine

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

  Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose

  2 hours post-dose

• Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

  MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose

  2 hours post-dose

Secondary Outcomes (14)

• Percentage of Participants With Pain Relief at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Return to Normal Function at 2 Hours Post-dose

  2 hours post-dose

• Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose

  From 2 hours up to 24 hours post-dose

• Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose

  From 2 hours up to 48 hours post-dose

• Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose

  From 2 hours up to 24 hours post-dose

Study Arms (3)

BHV-2100 75 mg

EXPERIMENTAL

Drug: BHV-2100

BHV-2100 150 mg

EXPERIMENTAL

Drug: BHV-2100

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

matching placebo

Placebo

BHV-2100 DRUG

BHV-2100 75mg

BHV-2100 75 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
• 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.
• 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.

You may not qualify if:

• Participants with a history of basilar migraine or hemiplegic migraine.
• 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.
• Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before screening.
• 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.
• 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.
• 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.
• 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.
• Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers.
• Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (60)

MD First Research

Gilbert, Arizona, 85286, United States

Location

WR-PRI, LLC (Encino)

Encino, California, 91316, United States

Location

Cenexel CNS Los Alamitos

Los Alamitos, California, 90720, United States

Location

Clinical Research Institute

Los Angeles, California, 90048, United States

Location

WR-PRI, LLC (Newport Beach)

Newport Beach, California, 92660, United States

Location

Cenexel CIT IE

Riverside, California, 92506, United States

Location

Hasbani Neurology

New Haven, Connecticut, 06511, United States

Location

Ki Health Partners DBA/ New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Green Leaf Clinical Trials

Jacksonville, Florida, 32258, United States

Location

WR-MSRA (Multi-Specialty Research Associates)

Lake City, Florida, 32055, United States

Location

AppleMed Research Group

Miami, Florida, 33126, United States

Location

Ideal Research

Pembroke Pines, Florida, 33014, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Premier Research Instiute

West Palm Beach, Florida, 33407, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Chicago Headache Center & Research Center

Chicago, Illinois, 60657, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

Integrated Clinical Trials Services

West Des Moines, Iowa, 50265, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Crescent City Headache & Neurology

Chalmette, Louisiana, 70043, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Neurology Center of New England PC

Foxborough, Massachusetts, 02035, United States

Location

MedVadis Research Corp

Waltham, Massachusetts, 02451, United States

Location

Mass Institute of Clinical Research

Westborough, Massachusetts, 01581, United States

Location

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48112, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 47334, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

StudyMedrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, 64114, United States

Location

Clinvest Research

Springfield, Missouri, 65807, United States

Location

WR-CRNC (Wake Research)

Las Vegas, Nevada, 89118, United States

Location

ActivMed Practices & Research-Portsmouth/Pease

Portsmouth, New Hampshire, 03801, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Fieve Clinical Research, Inc.

New York, New York, 10017, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Velocity Clinical Research, Vestal

Vestal, New York, 13850, United States

Location

PharmQuest Life Sciences

Greensboro, North Carolina, 27408, United States

Location

Accellacare of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45424, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15410, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Columbia

Columbia, South Carolina, 29204, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

KCA Neurology

Franklin, Tennessee, 37067, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78732, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

DM Clinical Research - Belliare

Houston, Texas, 77081, United States

Location

Red Star Research, LLC

Lake Jackson, Texas, 77566, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

DM Clinical Research - Tomball

Tomball, Texas, 77375, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 28, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (60)