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

Phase 2 Double-Blind, Randomized, Placebo Controlled, Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: BHV-2100; Drug: BHV-2100

• Study Type: Interventional
• Enrollment (Actual): 647
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85286
      • MD First Research
  • California
    • Encino, California, United States, 91316
      • WR-PRI, LLC (Encino)
    • Los Alamitos, California, United States, 90720
      • Cenexel CNS Los Alamitos
    • Los Angeles, California, United States, 90048
      • Clinical Research Institute
    • Newport Beach, California, United States, 92660
      • WR-PRI, LLC (Newport Beach)
    • Riverside, California, United States, 92506
      • Cenexel CIT IE
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Hasbani Neurology
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners DBA/ New England Institute for Clinical Research
  • Florida
    • Jacksonville, Florida, United States, 32258
      • Green Leaf Clinical Trials
    • Lake City, Florida, United States, 32055
      • WR-MSRA (Multi-Specialty Research Associates)
    • Miami, Florida, United States, 33126
      • AppleMed Research Group
    • Pembroke Pines, Florida, United States, 33014
      • Ideal Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
    • West Palm Beach, Florida, United States, 33407
      • Premier Research Instiute
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research, Inc.
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research, Savannah
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center & Research Center
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network II, LLC
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trials Services
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Collective Medical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • Chalmette, Louisiana, United States, 70043
      • Crescent City Headache & Neurology
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research, Rockville
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Foxborough, Massachusetts, United States, 02035
      • Neurology Center of New England PC
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corp
    • Westborough, Massachusetts, United States, 01581
      • Mass Institute of Clinical Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48112
      • Michigan Head Pain and Neurological Institute
    • Farmington Hills, Michigan, United States, 47334
      • Quest Research Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMedrix Research
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research - Kansas City
    • Springfield, Missouri, United States, 65807
      • Clinvest Research
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • WR-CRNC (Wake Research)
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research-Portsmouth/Pease
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • New York, New York, United States, 10017
      • Fieve Clinical Research, Inc.
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research, Vestal
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences
    • Raleigh, North Carolina, United States, 27609
      • Accellacare of Raleigh
  • Ohio
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15410
      • Preferred Primary Care Physicians
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research, Columbia
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • KCA Neurology
  • Texas
    • Austin, Texas, United States, 78732
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • Houston, Texas, United States, 77081
      • DM Clinical Research - Belliare
    • Lake Jackson, Texas, United States, 77566
      • Red Star Research, LLC
    • Lewisville, Texas, United States, 75057
      • EPIC Clinical Research
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - Tomball
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98104
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; matching placebo
Experimental: BHV-2100 75 mg	Drug: BHV-2100; BHV-2100 75mg; Drug: BHV-2100; BHV-2100 150 mg
Experimental: BHV-2100 150 mg	Drug: BHV-2100; BHV-2100 75mg; Drug: BHV-2100; BHV-2100 150 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pain Relief at 2 Hours Post-dose	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief is defined as pain level of none or mild.	2 hours post-dose
Percentage of Participants With Return to Normal Function at 2 Hours Post-dose	Return to normal function at 2 hours post-dose is assessed using the percentage of subjects with a functional disability level of normal at 2 hours post-dose in the subset of subjects with functional disability at the time of dosing. Functional disability level is measured on a 4-point numeric rating scale (0=normal, 1=mildly impaired, 2=severely impaired, 3=requires bedrest), and functional disability is defined as mildly impaired, severely impaired, or requires bedrest.	2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief is defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 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	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief is defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 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	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom is defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.	From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom is defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.	From 2 hours up to 48 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose	Participants who do not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments has been completed on the eDiary) are permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication is recorded by the participant in a paper diary.	24 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose	Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse is defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who are pain-free at 2 hours post-dose.	From 2 hours up to 48 hours post-dose
Observed Plasma concentration in Patients After a Single Dose of BHV-2100		At 2, 8, and 24 hours post-dose
Number of Subjects with Clinically Significant Laboratory Abnormalities	To assess the tolerability and safety of BHV-2100. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.	Up to 11 weeks
Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs	To assess the tolerability and safety of BHV-2100. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, and moderate and severe AEs.	Up to 11 weeks
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose	Phonophobia (sensitivity to sound) status is measured as absent 2 hours postdose in the subset of subjects with phonophobia present at the time of dosing in the eDiary. Freedom from phonophobia is defined as phonophobia absent.	2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose	Photophobia (sensitivity to light) status is measured as absent 2 hours postdose in the subset of subjects with photophobia present at the time of dosing in the eDiary. Freedom from photophobia is defined as photophobia absent.	2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose	Nausea status is measured as absent 2 hours postdose in the subset of subjects with nausea present at the time of dosing in the eDiary. Freedom from nausea is defined as nausea absent.	2 hours post-dose

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acute Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV2100-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No