BHV-2100 for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called BHV-2100 to determine if it can safely reduce headache pain and other symptoms in people with migraines. Researchers test different doses of BHV-2100 and compare them to a placebo (a pill with no active ingredient) to identify the most effective dose. Individuals who have experienced migraines for at least a year, with 2-8 migraine attacks per month, may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications to join the trial?
The trial does not specify that you need to stop all current medications. If you are on a stable dose of prophylactic migraine medication for at least 3 months, you can continue taking it. However, you should not have used certain medications like moderate/strong CYP3A4 inhibitors or inducers, or p-gp or BCRP inhibitors in the past 30 days.
Is there any evidence suggesting that BHV-2100 is likely to be safe for humans?
Research has shown that BHV-2100 is very safe and easy to tolerate in earlier studies. These studies found no major side effects at various doses, indicating that BHV-2100 is generally well-tolerated. The treatment is being tested to determine its effectiveness in reducing migraine pain and other symptoms. While the current trial is still determining the best dose, earlier results positively highlight its safety.12345
Why do researchers think this study treatment might be promising for migraine?
Researchers are excited about BHV-2100 for migraine treatment because it offers a potentially new mechanism of action compared to existing options like triptans and CGRP inhibitors. BHV-2100 is believed to target specific pathways in the brain more precisely, which could lead to faster and more effective relief for migraine sufferers. Additionally, the trial includes different dosages (75 mg and 150 mg), allowing researchers to optimize the balance between efficacy and side effects. This innovative approach positions BHV-2100 as a promising candidate in the quest for improved migraine therapies.
What evidence suggests that BHV-2100 might be an effective treatment for migraine?
Research has shown that BHV-2100 is a promising new treatment for migraines. It blocks a protein called TRPM3, which sends pain signals. Early results indicate that single doses of BHV-2100 are absorbed quickly and maintain effective levels in the body. This suggests it might help reduce headache pain and other migraine symptoms. In this trial, participants will receive either a 75 mg or 150 mg dose of BHV-2100 to determine which is most effective.23567
Are You a Good Fit for This Trial?
This trial is for individuals who experience migraine headaches. Specific details about eligibility criteria are not provided, but typically participants must have a history of migraines and meet certain health conditions to be included.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BHV-2100 or placebo for the acute treatment of migraine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-2100
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor