Safety and Efficacy Study in Adult Subjects With Acute Migraines

Pfizer1,485 enrolled

Overview

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,485

Conditions

Migraine, With or Without Aura

Interventions

RimegepantDRUG

75 mg tablet QD

PlaceboDRUG

Placebo tablet to match rimegepant dose QD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version\[1\] including the following: * Not more than 8 attacks of moderate or severe intensity per month within last 3 months * Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period 2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period 3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry. 4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria. Key Exclusion Criteria: 1. Patient history of HIV disease 2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients 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 patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled) 4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments 5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption 6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known 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 7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.

Locations (50)

Outcomes

Primary Outcomes

Percentage of Participants With Freedom From Pain at 2 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

Time frame: 2 hours post-dose

Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose

MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.

Time frame: 2 hours post-dose

Secondary Outcomes

Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose

Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.

Time frame: 2 hours post-dose

Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose

Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.

Time frame: 2 hours post-dose

Percentage of Participants With Pain Relief at 2 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.

Time frame: 2 hours post-dose

Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose

Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.

Data from ClinicalTrials.gov

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Central Research Associates, Inc

Birmingham, Alabama, United States

Neurological Physicians of Arizona/Radiant Research Inc

Gilbert, Arizona, United States

Clinical Research Consortium Arizona

Tempe, Arizona, United States

Radiant Research, Inc.

Tucson, Arizona, United States

Woodland International Research Group, LLC

Little Rock, Arkansas, United States

Pharmacology Research Institute

Encino, California, United States

Optimus Medical Group

San Francisco, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

Diablo Clinical Research, Inc

Walnut Creek, California, United States

Qps Mra, Llc

Hollywood, Florida, United States

...and 40 more locations

Time frame: 2 hours post-dose

Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose

Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were 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 was recorded by the participant in a paper diary.

Time frame: 24 hours post-dose

Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was 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 Relief From 2 to 24 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was 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.

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 were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was 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 Sustained Pain Relief From 2 to 48 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was 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 Pain Relapse From 2 to 48 Hours Post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.

Time frame: From 2 hours up to 48 hours post-dose

Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose

Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.

Time frame: 2 hours post-dose