Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,499

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach

1 country

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

July 27, 2017

Completed

Same day until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed

6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

December 23, 2020

Completed

Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

July 27, 2017

Results QC Date

November 30, 2020

Last Update Submit

February 14, 2023

Conditions

Migraine, With or Without Aura

Outcome Measures

Primary Outcomes (2)

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.
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.
2 Hours

Secondary Outcomes (11)

Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
24 hours post-dose
+6 more secondary outcomes

Study Arms (2)

Rimegepant 75 mg

EXPERIMENTAL

Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

Drug: Rimegepant

Placebo

PLACEBO COMPARATOR

Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.

Drug: Placebo

Interventions

RimegepantDRUG

75 mg tablet QD

Also known as: BHV-3000

Rimegepant 75 mg

PlaceboDRUG

Placebo tablet to match rimegepant dose QD

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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
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.
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

You may not qualify if:

Patient history of HIV disease
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.
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)
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
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
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, hepatitisB 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 ofthe trial
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 thepast 12 months from the date of the screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (50)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Thunderbird Internal Medicine / Radiant Research, Inc.

Glendale, Arizona, 85306, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pacific Research Partners LLC

Oakland, California, 94607, United States

Location

National Research Institute

Panorama City, California, 91402, United States

Location

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, 91403, United States

Location

Clinical Trials of the Rockies

Denver, Colorado, 80209, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32256, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Radiant Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Savannah Neurology Specialists

Savannah, Georgia, 31406, United States

Location

Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

PMG Research of McFrland Clinic

Ames, Iowa, 50010, United States

Location