Safety and Efficacy Study in Adult Subjects With Acute Migraines
- Registration Number
- NCT03235479
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1485
-
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.
Key
- 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 mal-absorption
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Rimegepant 75 mg Rimegepant 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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 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 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 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 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 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 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 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 for the participants who were pain-free at 2 hours post-dose.
Trial Locations
- Locations (47)
Neurological Physicians of Arizona/Radiant Research Inc
🇺🇸Gilbert, Arizona, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Central Research Associates, Inc
🇺🇸Birmingham, Alabama, United States
Clinical Research Institute, Inc
🇺🇸Minneapolis, Minnesota, United States
Clinical Research Consortium- Las Vegas
🇺🇸Las Vegas, Nevada, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Texas Center for Drug Development
🇺🇸Houston, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Clinical Research Associates of Tidewater, Inc.
🇺🇸Norfolk, Virginia, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
Michigan Head Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Oregon Center for Clinical Investigations, Inc
🇺🇸Portland, Oregon, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Fieve Clinical Research
🇺🇸New York, New York, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
J.Lewis Research Inc. / Jordan River Family Med
🇺🇸South Jordan, Utah, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
PharmQuest, LLC
🇺🇸Greensboro, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
J.Lewis Research Inc / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Meridian Clinical Research -Norfolk
🇺🇸Norfolk, Nebraska, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Milford Emergency Associates, Inc.
🇺🇸Marlborough, Massachusetts, United States
Pharmacology Research Institute
🇺🇸Encino, California, United States
Clinical Research Consortium Arizona
🇺🇸Tempe, Arizona, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
California Medical Clinic for Headache
🇺🇸Santa Monica, California, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Diablo Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
Qps Mra, Llc
🇺🇸Miami, Florida, United States
Multi-Specialty Research Associates, Inc
🇺🇸Lake City, Florida, United States
Ormond Medical Arts Pharmaceutical Research
🇺🇸Ormond Beach, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Boston Clinical Trials, Inc
🇺🇸Boston, Massachusetts, United States
FutureSearch Trials of Neurology, LP
🇺🇸Dallas, Texas, United States
Hassman Research Institute, LLC
🇺🇸Berlin, New Jersey, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Radiant Research, Inc.
🇺🇸Tucson, Arizona, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Seattle Women's:Health, Research & Gynecology
🇺🇸Seattle, Washington, United States