MigrainePhase 2NCT06603623
Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
A Phase 2 study testing BHV-2100 in people with Migraine, run by Biohaven Therapeutics Ltd. at 60 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine
- What is being tested?
- BHV-2100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 647 participants
- Where
- 60 sitesUnited States
- Study dates
- 10 Oct 2024to 28 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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.
- 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.
Who cannot join
- 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.
- 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.
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- 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.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48112
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78732
Northwest Clinical Research Center
Bellevue, Washington, 98007
Boston Clinical Trials
Boston, Massachusetts, 02131
Crescent City Headache & Neurology
Chalmette, Louisiana, 70043
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Chicago Headache Center & Research Center
Chicago, Illinois, 60657
StudyMedrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Columbia
Columbia, South Carolina, 29204
Zenos Clinical Research
Dallas, Texas, 75230
Hometown Urgent Care and Research
Dayton, Ohio, 45424
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
WR-PRI, LLC (Encino)
Encino, California, 91316
Quest Research Institute
Farmington Hills, Michigan, 47334
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422
Neurology Center of New England PC
Foxborough, Massachusetts, 02035
KCA Neurology
Franklin, Tennessee, 37067
MD First Research
Gilbert, Arizona, 85286
PharmQuest Life Sciences
Greensboro, North Carolina, 27408
DM Clinical Research - Belliare
Houston, Texas, 77081
Green Leaf Clinical Trials
Jacksonville, Florida, 32258
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114
WR-MSRA (Multi-Specialty Research Associates)
Lake City, Florida, 32055
Red Star Research, LLC
Lake Jackson, Texas, 77566
WR-CRNC (Wake Research)
Las Vegas, Nevada, 89118
Epic Clinical Research
Lewisville, Texas, 75057
Cenexel CNS Los Alamitos
Los Alamitos, California, 90720
Clinical Research Institute
Los Angeles, California, 90048
L-MARC Research Center
Louisville, Kentucky, 40213
AppleMed Research Group
Miami, Florida, 33126
Clinical Research Institute
Minneapolis, Minnesota, 55402
Hasbani Neurology
New Haven, Connecticut, 06511
DelRicht Research
New Orleans, Louisiana, 70115
Fieve Clinical Research, Inc.
New York, New York, 10017
WR-PRI, LLC (Newport Beach)
Newport Beach, California, 92660
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Collective Medical Research
Overland Park, Kansas, 66210
Ideal Research
Pembroke Pines, Florida, 33014
ActivMed Practices & Research-Portsmouth/Pease
Portsmouth, New Hampshire, 03801
Accellacare of Raleigh
Raleigh, North Carolina, 27609
Cenexel CIT IE
Riverside, California, 92506
Rochester Clinical Research
Rochester, New York, 14609
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Seattle Clinical Research Center
Seattle, Washington, 98104
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
Clinvest Research
Springfield, Missouri, 65807
Ki Health Partners DBA/ New England Institute for Clinical Research
Stamford, Connecticut, 06905
ForCare Clinical Research
Tampa, Florida, 33613
DM Clinical Research - Tomball
Tomball, Texas, 77375
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15410
Velocity Clinical Research, Vestal
Vestal, New York, 13850
MedVadis Research Corp
Waltham, Massachusetts, 02451
Integrated Clinical Trials Services
West Des Moines, Iowa, 50265
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Premier Research Instiute
West Palm Beach, Florida, 33407
Mass Institute of Clinical Research
Westborough, Massachusetts, 01581
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- BHV-2100, Placebo
- Keywords
- Acute Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-2100Drug
BHV-2100 75mg
BHV-2100Drug
BHV-2100 150 mg
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| BHV-2100 75 mg | Experimental | Not described Receives: Drug: BHV-2100 |
| BHV-2100 150 mg | Experimental | Not described Receives: Drug: BHV-2100 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 hours post-dose
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2 hours up to 48 hours post-dose
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.
Measured: 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.
Measured: 2 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.
Measured: 24 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.
Measured: 2 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.
Measured: From 2 hours up to 48 hours post-dose
Observed Plasma concentration in Patients After a Single Dose of BHV-2100
Measured: At 2, 8, and 24 hours post-dose
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.
Measured: Up to 11 weeks
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.
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2024
- Primary completion24 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603623
- Sponsor's protocol ID
- BHV2100-201
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double-Blind, Randomized, Placebo Controlled, Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT06603623
- Acronym / sponsor ID
- BHV2100-201
- Conditions
- Migraine
- Keywords
- Acute Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BHV-2100 75 mg | Experimental | Drug: BHV-2100 |
| BHV-2100 150 mg | Experimental | Drug: BHV-2100 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-2100BHV-2100 75mg | Drug | BHV-2100 75 mg |
| BHV-2100BHV-2100 150 mg | Drug | BHV-2100 150 mg |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Time frame: 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
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Time frame: 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
14 secondary outcomes
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Return to Normal Function at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Time frame: 24 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Observed Plasma concentration in Patients After a Single Dose of BHV-2100
Time frame: At 2, 8, and 24 hours post-dose
Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs
Time frame: Up to 11 weeks
Number of Subjects with Clinically Significant Laboratory Abnormalities
Time frame: Up to 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHV-2100 in people with Migraine, run by Biohaven Therapeutics Ltd. at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.