BHV-2100 for Migraine

No longer recruiting at 65 trial locations
CM
Overseen ByChief Medical Officer
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Biohaven Therapeutics Ltd.
Must be taking: Prophylactic migraine
Prior Safety DataThis treatment has passed at least one previous human trial

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

I've had 2-8 moderate or severe migraines monthly for the last 3 months.
I have been on a stable dose of my migraine prevention medication for at least 3 months.
I have been diagnosed with migraines for at least 1 year.
See 1 more

Exclusion Criteria

Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before 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
I have used strong medication that affects liver enzymes in the last 30 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-2100 or placebo for the acute treatment of migraine

Up to 11 weeks
Multiple visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BHV-2100
Trial Overview The study aims to determine the safety and effectiveness of at least one dose of BHV-2100 in alleviating headache pain and other symptoms associated with migraines, compared to a placebo (a substance with no active drug).
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-2100 75 mgExperimental Treatment1 Intervention
Group II: BHV-2100 150 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials
13
Recruited
4,800+

Published Research Related to This Trial

Greater occipital nerve (GON) blockade has been reported as an effective treatment for aborting basilar-type migraine (BTM), especially in cases with significant suboccipital tenderness.
This case suggests that GON blockade could be a valuable alternative for managing acute BTM, where traditional migraine medications like triptans are contraindicated.
Acute treatment of basilar-type migraine with greater occipital nerve blockade.Baron, EP., Tepper, SJ., Mays, M., et al.[2010]
Zavegepant is a potent CGRP receptor antagonist that has shown effectiveness in treating migraines through intranasal delivery in clinical trials, demonstrating a high binding affinity to the receptor.
Research led to the development of compound 21, which maintains strong receptor binding while significantly improving oral bioavailability from 1.7% to 17%, suggesting a promising alternative for migraine treatment.
Azepino-indazoles as calcitonin gene-related peptide (CGRP) receptor antagonists.Mercer, SE., Chaturvedula, PV., Conway, CM., et al.[2021]
TRV250, a selective delta opioid receptor agonist, was well tolerated in a study of 38 healthy adults, showing no serious adverse events and only mild side effects, indicating a favorable safety profile for potential migraine treatment.
The pharmacokinetics of TRV250 demonstrated dose-proportional increases in plasma exposure, with oral bioavailability ranging from 14% to 19% compared to subcutaneous administration, suggesting it could be an effective option for acute migraine management.
A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.Fossler, MJ., Schmith, V., Greene, SA., et al.[2021]

Citations

Efficacy and Safety Trial of BHV-2100 for the Acute ...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 ...
BHV-2100, a First-in-Class TRPM3 Antagonist ...BHV-2100 is a first-in-class TRPM3 antagonist being studied for acute treatment of migraine with the potential to address the needs of millions of patients.
Safety, Tolerability, and Pharmacokinetics of BHV-2100, a ...advancement of BHV-2100 into clinical trials for migraine and pain as a novel, peripherally acting, nonopioid treatment. ACKNOWLEDGMENTS: This study was ...
Phase 2 Migraine Study of TRPM3 Antagonist BHV-2100 ...In the study, patients with acute migraine will be randomly assigned to either BHV-2100 in doses of 75 mg or 150 mg, or placebo, with outcomes ...
Biohaven Initiates Pivotal Trial of Novel Investigational ...Single doses of BHV-2100 demonstrated rapid absorption and sustained concentrations above predicted efficacious levels at all doses tested ...
Efficacy and Safety Trial of BHV-2100 for the Acute ...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 ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40194374/
Safety, Tolerability, and Pharmacokinetics of BHV-2100, a ...BHV-2100 demonstrated excellent safety and pharmacokinetics and is being evaluated in clinical trials for pain (EudraCT 2024-512187-57) and ...
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