Migraine, With or Without AuraPhase 3NCT03461757
Trial in Adult Subjects With Acute Migraines
A Phase 3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 69 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, With or Without Aura
- What is being tested?
- Rimegepant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,811 participants
- Where
- 69 sitesUnited States
- Study dates
- 27 Feb 2018to 15 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subject 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:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Not more than 8 attacks of moderate to severe intensity per month within the 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.
- Subjects 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 screening visit and the dose is not expected to change during the course of the study.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Who cannot join
- Subject with a history of HIV disease
- 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
- 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 being enrolled)
- Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
- The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., 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.
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- History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
- Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
- Participation in any other investigational clinical trial while participating in this clinical trial
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Synexus
Atlanta, Georgia, 30328
Heartland Research Associates LLC
Augusta, Kansas, 67010
Tekton Research, Inc
Austin, Texas, 78745
Northwest Clinical Research Center
Bellevue, Washington, 98007
Hassman Research Institute
Berlin, New Jersey, 08009
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Cresent City Headache and Neurology Center LLC
Chalmette, Louisiana, 70043
Charlottesville Medical Research
Charlottesville, Virginia, 22911
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303
Radiant Research, Inc.
Columbus, Ohio, 43212
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Hometown Urgent Care and Research
Dayton, Ohio, 45424
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Aventiv Research Inc
Dublin, Ohio, 43016
Pharmacology Research Institute
Encino, California, 91316
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721
Ventavia Research Group, LLC
Fort Worth, Texas, 76104
PharmQuest, LLC
Greensboro, North Carolina, 27408
MD Clinical
Hallandale, Florida, 33009
AGA Clinical Trials
Hialeah, Florida, 33012
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
CNS Research Science, Inc.
Jamaica, New York, 11432
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144
Volunteer Research Group
Knoxville, Tennessee, 37920
eStudySite
La Mesa, California, 91942
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
Red Star Research
Lake Jackson, Texas, 77566
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Pharmacology Research Institute
Los Alamitos, California, 90720
Community Clinical Research Network/Milford Emergency Associates, Inc
Marlborough, Massachusetts, 01752
Qps Mra, Llc
Miami, Florida, 33143
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55042
Coastal Clinical Research, LLC
Mobile, Alabama, 36608
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464
Clinical Research Institute, Inc.
Nashville, Tennessee, 37203
Nashville Neuroscience Group
Nashville, Tennessee, 37203
Synergy San Diego
National City, California, 91950
Yale University
New Haven, Connecticut, 06519
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
DelRicht Research
New Orleans, Louisiana, 70124
Pharmacology Research Institute
Newport Beach, California, 92660
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, 32174
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
PMG Research of Raleigh
Raleigh, North Carolina, 27609
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Optimus Medical Group
San Francisco, California, 94102
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Sundance Clinical Research
St Louis, Missouri, 63141
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, 06905
Clinical Research Consortium, An AMR Company
Tempe, Arizona, 85283
DM Clinical Research
Tomball, Texas, 77375
Radiant Research, Inc.
Tucson, Arizona, 85712
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Heartland Research Associates, LLC
Wichita, Kansas, 67205
Wilmington Health, PLLC
Wilmington, North Carolina, 28401
About this study
Official title: BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
- Conditions
- Migraine, With or Without Aura
- Being tested
- Rimegepant, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Also called BHV-3000
75 mg ODT QD
PlaceboDrug
Placebo ODT to match rimegepant dose QD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Rimegepant 75 mg | Experimental | Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Receives: Drug: Rimegepant |
| Arm 2: Placebo | Placebo comparator | Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours post-dose
Secondary outcomes (21)
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.
Measured: 2 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.
Measured: 2 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.
Measured: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 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. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Measured: From 2 hours up to 24 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.
Measured: 24 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 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. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.
Measured: 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 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.
Measured: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 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. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Measured: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 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. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.
Measured: From 2 hours up to 48 hours post-dose
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.
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 90 Minutes 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.
Measured: 90 minutes post-dose
Percentage of Participants With Pain Relief at 90 Minutes 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.
Measured: 90 minutes 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.
Measured: From 2 hours up to 24 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes 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.
Measured: 90 minutes post dose
Percentage of Participants With Freedom From Pain at 90 Minutes 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.
Measured: 90 minutes 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.
Measured: 2 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.
Measured: From 2 hours up to 48 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes 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.
Measured: 60 minutes post-dose
Percentage of Participants With Freedom From Functional Disability at 60 Minutes 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.
Measured: 60 minutes 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.
Measured: 2 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 post-dose for the participants who were pain-free at 2 hours post-dose.
Measured: From 2 hours up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start27 Feb 2018
- Primary completion8 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Migraine, With or Without AuraStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461757
- Sponsor's protocol ID
- BHV3000-303
- Status last verified
- Dec 2022
- First submitted
- 6 Mar 2018
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vieira JR, Fajardo M, Abbott C, Li J, Sellix MT. Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Adults of Hispanic or Latino Ethnicity: Post Hoc Analysis of Three Randomized, Placebo-Controlled Trials. Neurol Ther. 2026 Oct 6. doi: 10.1007/s40120-026-01025-8. Online ahead of print.
PubMed 42839212Charleston L 4th, Armand CE, Monteith TS, O'Brien HL, Abbott CC, Pixton GC, Fullerton T. Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials. Headache. 2026 Apr;66(4):874-884. doi: 10.1111/head.70034. Epub 2026 Feb 6.
PubMed 41652666Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.
PubMed 36739511Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
PubMed 36125279Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.
PubMed 31311674
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT03461757
- Acronym / sponsor ID
- BHV3000-303
- Conditions
- Migraine, With or Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,811 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Rimegepant 75 mg | Experimental | Drug: RimegepantParticipants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
| Arm 2: Placebo | Placebo comparator | Drug: PlaceboParticipants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Subject 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:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Not more than 8 attacks of moderate to severe intensity per month within the 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
Key exclusion criteria (9 listed)
- Subject with a history of HIV disease
- 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
- 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 being enrolled)
- Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantAlso: BHV-300075 mg ODT QD | Drug | Arm 1: Rimegepant 75 mg |
| PlaceboPlacebo ODT to match rimegepant dose QD | Drug | Arm 2: Placebo |
Primary outcome
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
Time frame: 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.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Time frame: 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.
21 secondary outcomes
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
Time frame: 24 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 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 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose
Time frame: 90 minutes post-dose
Percentage of Participants With Pain Relief at 90 Minutes Post-dose
Time frame: 90 minutes post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose
Time frame: 90 minutes post dose
Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose
Time frame: 90 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Time frame: 60 minutes post-dose
Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose
Time frame: 60 minutes post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Time frame: 2 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
Time frame: From 2 hours up to 48 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42839212Vieira JR, Fajardo M, Abbott C, Li J, Sellix MT. Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Adults of Hispanic or Latino Ethnicity: Post Hoc Analysis of Three Randomized, Placebo-Controlled Trials. Neurol Ther. 2026 Oct 6. doi: 10.1007/s40120-026-01025-8. Online ahead of print.
- Derived from this study: PubMed 41652666Charleston L 4th, Armand CE, Monteith TS, O'Brien HL, Abbott CC, Pixton GC, Fullerton T. Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials. Headache. 2026 Apr;66(4):874-884. doi: 10.1111/head.70034. Epub 2026 Feb 6.
- Derived from this study: PubMed 36739511Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.
- Derived from this study: PubMed 36125279Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
- Derived from this study: PubMed 31311674Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimegepant in people with Migraine, With or Without Aura, run by Pfizer at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461757, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.