Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

Biohaven Therapeutics Ltd.647 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

647

Conditions

Migraine

Interventions

BHV-2100DRUG

BHV-2100 75mg

BHV-2100DRUG

BHV-2100 150 mg

PlaceboDRUG

matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 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: 1. 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. 2. 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. 3. 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: 1. Participants with a history of basilar migraine or hemiplegic migraine. 2. 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. 3. Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before screening. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers. 10. Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.

Locations (60)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 2 hours post-dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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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

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.

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

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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: Up to 11 weeks