Acute Treatment Trial in Adult Subjects With Migraines
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT03872453
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2154
Key Inclusion Criteria:
-
Participants have 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, 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.
-
At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout 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 throughout the Screening Period.
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Participants 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.
-
Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Key Exclusion Criteria:
- Participant with a history of basilar migraine or hemiplegic migraine.
- Participant with a history of human immunodeficiency virus (HIV) disease.
- Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack 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).
- Participant has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (for example, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
- Participant 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 participant has a history of current or evidence of any significant and/ or unstable medical conditions (for example, 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 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 Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM-V) criteria for any significant substance use disorder within the past 12 months from the date of the Screening Visit.
- History of nasal surgery in the 6 months preceding the Screening Visit.
- 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 Zavegepant 5 mg Intranasal Aptar Pharma Unit Dose System Participants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device. Zavegepant 10 mg Intranasal Aptar Pharma Unit Dose System Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. Zavegepant 20 mg Zavegepant Participants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. Zavegepant 20 mg Intranasal Aptar Pharma Unit Dose System Participants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. Placebo Zavegepant matching placebo Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. Placebo Intranasal Aptar Pharma Unit Dose System Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. Zavegepant 5 mg Zavegepant Participants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device. Zavegepant 10 mg Zavegepant Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device.
- 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 eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack 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 clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.
- Secondary Outcome Measures
Name Time Method 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 eCOA handheld device. Pain relief was defined as pain level of none or mild.
Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose 2 hours post-dose Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose Through 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 eCOA handheld device) 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 (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.
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 eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.
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 eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.
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 eCOA handheld device. Pain relief was defined as pain level of none or mild.
Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose 60 minutes post-dose Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
Percentage of Participants With Pain Relief at 30 Minutes Post-dose 30 minutes post-dose Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.
Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose 30 minutes post-dose Functional disbaility level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.
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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.
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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 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 eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.
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 eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.
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 eCOA handheld device. Freedom from nausea was defined as nausea absent post-odse in the subset of participants with nausea present at on-study migraine attack onset.
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 eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.
Trial Locations
- Locations (75)
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
eStudySite
🇺🇸La Mesa, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Center for Pharmaceutical Research, LLC
🇺🇸Kansas City, Missouri, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Phoenix Medical Research
🇺🇸Prairie Village, Kansas, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Family Medicine Specialists/CIS
🇺🇸Wauconda, Illinois, United States
Ki Health Partners, LLC, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Crescent City Headache and Neurology Center, LLC
🇺🇸Chalmette, Louisiana, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Meritas Health Neurology
🇺🇸North Kansas City, Missouri, United States
Wilmington Health, PLLC
🇺🇸Wilmington, North Carolina, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Clinical Investigation Specialists, Inc.
🇺🇸Kenosha, Wisconsin, United States
Ventavia Research Group
🇺🇸Fort Worth, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research
🇺🇸Bellevue, Washington, United States
Denver Neurological Research, LLC
🇺🇸Denver, Colorado, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Dynamed Clinical Research
🇺🇸Tomball, Texas, United States
Advanced Pharmaceutical Development Clinical Research
🇺🇸Magnolia, Texas, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
AGA Clinical Trials
🇺🇸Miami, Florida, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Community Clinical Research Network
🇺🇸Marlborough, Massachusetts, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Regeneris Medical
🇺🇸North Attleboro, Massachusetts, United States
Michigan Head Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
QPS Bio-Kinetic Clinical Applications, LLC
🇺🇸Springfield, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Clinical Neuroscience Solutions DBA CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Victorium Clinical Research
🇺🇸San Antonio, Texas, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Qps Mra, Llc
🇺🇸Miami, Florida, United States
Clinical Research Institute, Inc.
🇺🇸Plymouth, Minnesota, United States
Red Star Research, LLC
🇺🇸Lake Jackson, Texas, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
🇺🇸Salem, Oregon, United States
Alliance for Multispecialty Research/New Orleans Center for Clinical Research/Volunteer Research
🇺🇸Knoxville, Tennessee, United States
Montefiore Medical Center: Headache Center
🇺🇸Bronx, New York, United States
MedPharmics, LLC
🇺🇸Biloxi, Mississippi, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States