Acute Migraine Study

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Acute Migraine
A Study to Evaluate the Efficacy and Safety of BHV-2100 in Migraine

Do you or someone you love suffer from migraine?

We are conducting a clinical trial to determine whether BHV-2100 is safe and effective in reducing headache pain and other symptoms in the treatment of migraine.

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Enrolling Patients
NCT06603623
Phase 2
60 Study Locations
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Length of Study

11 Weeks
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# Study Visits

3
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Post-study Follow Up

No Follow up
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Who’s Included?

Adults

18–64
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Drug & Formulation

BHV-2100

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Possibility of Placebo

Yes

What is Migraine?

Migraines are a common health issue, affecting about 15% of people. They are the second biggest cause of disability, more disabling than any other neurological condition. Migraines happen when a part of the nervous system, called the trigeminovascular system, becomes overly sensitive. This sensitivity causes the intense headaches associated with migraines. Recent studies suggest that inflammation in the nervous system and certain receptors, known as TRPM3, may play a key role in triggering this sensitivity.

Study Criteria

The study will include male and female participants 18-64 years of age and older with at least a one-year history of migraine (with or without aura), including age of onset before 50, migraine attacks that last 4 – 72 hours, who have experienced between 2 and 8 attacks of moderate or severe intensity, and fewer than 15 headache days per month, within the last 3 months prior to screening.

Participants must be in good health (no uncontrolled medical problems), no psychiatric disorders or drug use . 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 ot used a neuromodulation device for migraine treatment over the preceding 3 months before screening are excluded.

  • Participants Must:

  • 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.
  • Participants Must Not:

  • 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 with uncontrolled medical problems, psychiatric disorders, or drug use.

Learn more about the benefits of joining our trial and see if you qualify today!

Frequently Asked Questions

About 575 people will participate in this study.

The study is being conducted by Biohaven.

The study lasts up to 11 weeks including 3 clinic visits.

Visit the See if You Qualify page, click on the location near you and fill out the form if you want to be referred to that site. A clinician will determine if you qualify for the study.

Learn more about the benefits of joining our trial and see if you qualify today!