Randomized Trial in Adult Participants With Acute Migraines
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Acute Migraine, Phonophobia, Photophobia, Nausea
Eligibility Criteria
Inclusion Criteria:
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, 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 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.
- Male and Female subjects ≥18 years of age.
Exclusion Criteria:
- 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).
- Subjects with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder.
- 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.
- History of nasal surgery in the 6 months.
- Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma)
- Participation in any other investigational clinical trial while participating in this clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized under FDA emergency use authorization or approval) who are at least 30 days post last dose of the vaccine are permitted to be screened for this study.
Sites / Locations
- Medical Affiliated Research Center
- Coastal Clinical Research, LLC, An AMR Co.
- MD First Research
- Tucson Neuroscience Research
- Baptist Health Center for Clinical Research
- Axiom Research, LLC
- Pharmacology Research Institute
- eStudySite
- Synergy San Diego
- Collaborative Neuroscience Network, LLC
- Pharmacology Research Institute
- Clinical Research Institute
- Wr-Pri, Llc
- Artemis Institute for Clinical Research
- Artemis Institute for Clinical Research
- California Neuroscience Research Medical Group, Inc.
- CT Clinical Research
- Ki Health Partners, LLC dba New England Institute for Clinical Research
- Neurology Offices of South Florida
- Clinical Neuroscience Solutions, Inc.
- Multi-Specialty Research Associates, Inc.
- Meridien Research
- AppleMed Research Group, LLC
- The Neurology Research Group
- Clinical Neuroscience Solutions, Inc.
- Clinical Neuroscience Solutions, Inc.
- Complete Health Research
- Ideal Clinical Research
- Clinical Research Center of Florida
- Clin-Med Research & Development, LLC
- ForCare Clinical Research
- JSV Clinical Research Study, Inc.
- iResearch Atlanta, LLC
- Meridian Clinical Research, LLC
- Northwest Clinical Trials Inc.
- Cedar Crosse Research Center
- Healthcare Research Network II, LLC
- Fort Wayne Neurological Center
- Collective Medical Research
- Alliance for Multispecialty Research, LLC
- L-MARC Research Center
- Crescent City Headache and Neurology Center
- DelRicht Research
- Boston Clinical Trials
- Community Clinical Research Network
- Boston Neuro Research Center
- Medvadis Research Corporation
- Michigan Headache and Neurological Institute
- Clinical Research Institute, Inc.
- Healthcare Research Network
- Sundance Clinical Research, LLC
- StudyMetrix Research
- Clinvest Research LLC
- Excel Clinical Research
- Center for Emotional Fitness
- Albuquerque Clinical Trials, Inc.
- Dent Neurosciences Research Center
- Montefiore Medical Center: Headache Center
- Regional Clinical Research
- Central New York Clinical Research
- Fieve Clinical Research, Inc
- Rochester Clinical Research, Inc.
- Headache Wellness Center
- PharmQuest LLC
- PMG of Raleigh, LLC
- Wilmington Health, PLLC
- Hometown Urgent Care & Research/ Wellnow
- Hometown Urgent Care and Research
- Hometown Urgent Care and Research
- The Orthopedic Foundation
- OK Clinical Research LLC
- Tekton Research, Inc.
- Summit Research Network
- Clinical Research of Philadelphia, LLC
- Preferred Primary Care Physicians, Inc.
- Preferred Primary Care Physicians, Inc.
- MD First Research
- Coastal Carolina Research Center
- Volunteer Research Group
- Clinical Neuroscience Solutions, Inc.
- FutureSearch Trials of Neurology
- Donald J. Garcia, Jr, MD, PA
- FutureSearch Trials of Dallas, LP
- Red Star Research LLC
- Clinical Trials of Texas, Inc. (CTT)
- DM Clinical Research
- Alpine Medical Group
- J. Lewis Research, Inc. / Jordan River Family Medicine
- Charlottesville Medical Research Center, LLC
- Health Research of Hampton Roads, Inc.
- Tidewater Integrated Medical Research
- Northwest Clinical Research Center
- Seattle Women's: Health, Research, Gynecology
- Clinical Investigation Specialist, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Zavegepant
Placebo
Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.
Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.