A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Pfizer

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: BHV-3500 (zavegepant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04804033

BHV3500-302

C5301006 (Other Identifier)

Details and patient eligibility

About

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Enrollment: 538 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject has 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, including the following:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4 - 72 hours if untreated
3. Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
4. Eight or more migraine days during the Observation Period
5. 15 or more headache days during the Observation Period
6. One or more non-headache days during the Observation Period
7. Ability to distinguish migraine attacks from tension/cluster headaches
8. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

Exclusion criteria

1. Subject with a history of HIV disease
2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects 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
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
4. Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
5. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
7. Body mass index > 33 kg/m2
8. History of gallstones or cholecystectomy.
9. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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538 participants in 4 patient groups, including a placebo group

BHV-3500 200mg

Active Comparator group

Description:

Zavegepant 200mg oral soft gel capsule.

Treatment:

Drug: BHV-3500 (zavegepant)

Placebo 200mg

Placebo Comparator group

Description:

Matching placebo 200mg oral soft gel capsule.

Treatment:

Drug: Placebo

BHV-3500 100mg

Active Comparator group

Description:

Zavegepant 100mg oral soft gel capsule.

Treatment:

Drug: BHV-3500 (zavegepant)

Placebo 100mg

Placebo Comparator group

Description:

Matching placebo 100mg oral soft gel capsule.

Treatment:

Drug: Placebo