Trial in Adult Subjects With Acute Migraines
- Registration Number
- NCT03461757
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1811
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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
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Migraine attacks, on average, lasting about 4-72 hours if untreated
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Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
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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
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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.
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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.
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Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Key
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo Placebo 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. Arm 1: Rimegepant 75 mg Rimegepant 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Freedom From Pain at 2 Hours Post-dose 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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose 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.
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose 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.
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Pain Relief at 2 Hours Post-dose 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.
Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose 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.
Percentage of Participants With Pain Relief at 90 Minutes Post-dose 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.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose 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.
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose 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.
Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose 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.
Percentage of Participants With Pain Relief at 60 Minutes Post-dose 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.
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose 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.
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose From 2 hours up 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.
Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose 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.
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose 2 hours post-dose Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.
Trial Locations
- Locations (63)
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Clinical Investigation Specialists, Inc.
🇺🇸Kenosha, Wisconsin, United States
Wilmington Health, PLLC
🇺🇸Wilmington, North Carolina, United States
Heartland Research Associates LLC
🇺🇸Augusta, Kansas, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
PharmQuest, LLC
🇺🇸Greensboro, North Carolina, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Qps Mra, Llc
🇺🇸Miami, Florida, United States
Synexus
🇺🇸Atlanta, Georgia, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Clinical Research Consortium, An AMR Company
🇺🇸Tempe, Arizona, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
eStudySite
🇺🇸La Mesa, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Radiant Research, Inc.
🇺🇸Columbus, Ohio, United States
Coastal Clinical Research, LLC
🇺🇸Mobile, Alabama, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Synergy San Diego
🇺🇸National City, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
CNS Research Science, Inc.
🇺🇸Jamaica, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Aventiv Research Inc
🇺🇸Dublin, Ohio, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Neurology Diagnostics, Inc.
🇺🇸Dayton, Ohio, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Ventavia Research Group, LLC
🇺🇸Fort Worth, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Red Star Research
🇺🇸Lake Jackson, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
NECCR Primacare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Meridian Clinical Research, LLC
🇺🇸Norfolk, Nebraska, United States
Ormond Medical Arts Pharmaceutical Research
🇺🇸Ormond Beach, Florida, United States
Cresent City Headache and Neurology Center LLC
🇺🇸Chalmette, Louisiana, United States
Community Clinical Research Network/Milford Emergency Associates, Inc
🇺🇸Marlborough, Massachusetts, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Coastal Carolina Research
🇺🇸Mount Pleasant, South Carolina, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Clinical Research Institute, Inc.
🇺🇸Nashville, Tennessee, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
Yale University
🇺🇸New Haven, Connecticut, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States