BHV-2100 for Migraine

Recruiting at 63 trial locations

Overseen By Chief Medical Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Biohaven Therapeutics Ltd.

Must be taking: Prophylactic migraine

Must not be taking: Triptans, Opioids, NSAIDs, others

Disqualifiers: Basilar migraine, Hemiplegic migraine, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 11 weeks

575 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that BHV-2100 for Migraine is an effective treatment?

The available research does not provide specific data on BHV-2100 for Migraine. However, it mentions a study on rimegepant, another treatment for migraines, which showed improvements in patients' quality of life over a long period. This suggests that similar treatments can be effective. Additionally, other treatments like galcanezumab have shown a reduction in migraine days and improved functioning, indicating that there are effective options available for migraine treatment. ^{1 2 3 4 5}

What safety data exists for BHV-2100 in migraine treatment?

The provided research does not mention BHV-2100 specifically. However, it discusses the safety of other migraine treatments like methysergide and onabotulinumtoxinA. Methysergide had side effects in 34.2% of patients, leading to discontinuation in 10.4%, but these subsided after stopping the drug. OnabotulinumtoxinA was found to be safe and well-tolerated, with mild or moderate side effects, such as neck pain reported by 4.4% of patients. No new safety signals were identified in the observational study of onabotulinumtoxinA. ^{6 7 8 9 10}

Is the drug BHV-2100 a promising treatment for migraine?

The information provided does not mention BHV-2100 specifically, so we cannot determine if it is a promising treatment for migraine based on the given research articles. ^{11 12 13 14 15}

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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).

Participant Groups

Group I: BHV-2100 75 mg Experimental Treatment 1 Intervention

Group II: BHV-2100 150 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Findings from Research

In a study involving 695 patients, rimegepant 75 mg taken every other day showed a significant improvement in health-related quality of life (HRQoL) compared to placebo, with EQ-5D utility scores increasing by 0.10 after 12 weeks of treatment.

Patients who initially received placebo also experienced similar HRQoL improvements after switching to rimegepant, indicating that the treatment's benefits can be quickly realized and are sustained for up to 64 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Powell, LC., L'Italien, G., Popoff, E., et al.[2023]

In a study of 66 children with refractory epilepsy, BRV (brivaracetam) was found to be effective, with 30.3% experiencing over a 50% reduction in seizure frequency and 9% remaining seizure-free after treatment.

BRV was generally well-tolerated, with side effects reported in 24.2% of cases, primarily irritability and drowsiness, indicating it is a safe option for pediatric patients with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Brivaracetam in children with epilepsy. Ferragut Ferretjans, F., Soto Insuga, V., Bernardino Cuesta, B., et al.[2022]

Galcanezumab, administered monthly for up to 12 months, was found to be safe and effective in reducing the number of migraine headache days, with an average reduction of 5.6 days for the 120 mg dose and 6.5 days for the 240 mg dose among 270 patients.

The treatment showed comparable safety profiles for both doses, with only a small percentage of patients experiencing serious adverse events (3.7%) or discontinuing due to adverse events (4.8%), indicating good tolerability for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. Camporeale, A., Kudrow, D., Sides, R., et al.[2019]

In a study of 44 patients with chronic migraines, those who underwent peripheral trigger point deactivation surgery experienced significantly lower headache intensity and reduced work-related disabilities compared to those treated with botulinum neurotoxin A (BTA).

Both surgical and BTA treatments were effective in improving overall migraine-related outcomes over time, but the surgical group showed more pronounced benefits in specific measures of headache intensity and disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcomes between headache surgery and targeted botox injections: A prospective multicenter pilot study. Janis, JE., Hehr, J., Huayllani, MT., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 87 patients over 30 months, methysergide was found to be effective in preventing severe migraines, with 50.6% of patients reporting excellent or good results.

While methysergide can be a useful option for preventing common and cluster migraines, it had limited effectiveness on combined tension and vascular headaches, and side effects were experienced by 34.2% of patients, leading to discontinuation in 10.4% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

METHYSERGIDE (SANSERT) IN THE PREVENTION OF MIGRAINE: A CLINICAL TRIAL. LLOYD-SMITH, DL., MCNAUGHTON, FL.[2022]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

Botulinum toxin type A (BTX-A) is effective for preventing migraines, likely through a unique mechanism that does not rely on its muscle relaxation properties, as shown in various trials and case reports.

BTX-A has a favorable safety profile with rare and mild adverse events, and its long dosing interval of 3 months or more adds to its convenience, although further large-scale studies are needed to optimize its use as a first-line migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of botulinum toxin type A and its clinical applications in migraine headache. Silberstein, SD.[2019]

Onabotulinumtoxin A (OnabotA) has been shown to be effective in reducing the frequency and severity of chronic migraine, as evidenced by phase III clinical trials that demonstrated significant improvements in headache days and patient disability.

The treatment is considered safe and well-tolerated, with mostly mild to moderate side effects, making it a viable preventive option for patients suffering from chronic migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Onabotulinumtoxin A in the treatment of chronic migraine]. Láinez-Andrés, JM.[2018]

A study involving 1160 patients with chronic migraine showed that onabotulinumtoxinA is used effectively in routine clinical practice, with consistent treatment patterns observed across multiple countries.

The treatment was generally well-tolerated, with 25.1% of patients reporting at least one treatment-related adverse event, primarily neck pain, while 74.4% of patients expressed satisfaction with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Matharu, M., Pascual, J., Nilsson Remahl, I., et al.[2018]

Botulinum toxin type A (BTX-A) has been shown to be an effective and well-tolerated treatment for migraines, supported by evidence from an open-label study and two double-blind, placebo-controlled studies.

The pain relief from BTX-A may be due to its ability to inhibit acetylcholine and block the parasympathetic nervous system, with response varying based on characteristics of the patient's migraine history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A (BOTOX) for treatment of migraine. Binder, WJ., Brin, MF., Blitzer, A., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azepino-indazoles as calcitonin gene-related peptide (CGRP) receptor antagonists. Mercer, SE., Chaturvedula, PV., Conway, CM., et al.[2021]

In an open trial involving patients with refractory migraine who had not responded to three classes of prophylactic drugs, botulinum toxin type A (BT-A) showed significant improvement in pain intensity and headache frequency within 30 days, lasting up to three months.

The side effects of BT-A were mild and self-limited, suggesting that it is a safe treatment option for patients suffering from refractory migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in refractory chronic migraine: an open-label trial. Menezes, C., Rodrigues, B., Magalhães, E., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute treatment of basilar-type migraine with greater occipital nerve blockade. Baron, EP., Tepper, SJ., Mays, M., et al.[2010]

Botulinum toxin type A (BTX-A) has been shown to be an effective and well-tolerated treatment for migraines, supported by evidence from an open-label study and two double-blind, placebo-controlled studies.

The pain relief from BTX-A may be due to its ability to inhibit acetylcholine and block the parasympathetic nervous system, with response varying based on characteristics of the patient's migraine history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A (BOTOX) for treatment of migraine. Binder, WJ., Brin, MF., Blitzer, A., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of Brivaracetam in children with epilepsy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Functional outcomes between headache surgery and targeted botox injections: A prospective multicenter pilot study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

METHYSERGIDE (SANSERT) IN THE PREVENTION OF MIGRAINE: A CLINICAL TRIAL. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Review of botulinum toxin type A and its clinical applications in migraine headache. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

[Onabotulinumtoxin A in the treatment of chronic migraine]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A (BOTOX) for treatment of migraine. [2010]

12. England pubmed.ncbi.nlm.nih.gov

Azepino-indazoles as calcitonin gene-related peptide (CGRP) receptor antagonists. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in refractory chronic migraine: an open-label trial. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Acute treatment of basilar-type migraine with greater occipital nerve blockade. [2010]

15. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A (BOTOX) for treatment of migraine. [2019]