Phase
Condition
Chronic Pain
Oral Facial Pain
Pain (Pediatric)
Treatment
Placebo
BHV-3500 (zavegepant)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of
Headache Disorders, 3rd Edition, including the following:
Age of onset of migraines prior to 50 years of age
Migraine attacks, on average, lasting 4 - 72 hours if untreated
Per subject report, at least 15 headache days per month, at lest 8 migraine days permonth, and at least 1 headache-free day per month within the last 3 months prior tothe Screening Visit
Eight or more migraine days during the Observation Period
15 or more headache days during the Observation Period
One or more non-headache days during the Observation Period
Ability to distinguish migraine attacks from tension/cluster headaches
Subjects on prophylactic migraine medication are permitted to remain on 1 medicationwith possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change duringthe course of the study.
Exclusion
Exclusion Criteria:
Subject with a history of HIV disease
Subject history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), AcuteCoronary 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 (howeversubjects can be included who have stable hypertension and/or diabetes for at least 3months prior to screening).
Subjects with major depressive episode or anxiety disorder which require more than 1daily medication for each disorder or subjects with a major depressive episodewithin the last 12 months. Medications to treat major depressive disorder or ananxiety disorder must have been at a stable dose for at least 3 months prior to theScreening Visit.
Subjects with active chronic pain syndromes, other pain syndromes (includingtrigeminal neuralgia), psychiatric conditions, dementia, or significant neurologicaldisorders (other than migraine) that, in the Investigator's opinion interfere withstudy assessments of safety or efficacy.
Subject has a history of gastric, or small intestinal surgery (including GastricBypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease orcondition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causesmalabsorption.
Body mass index > 33 kg/m2
History of gallstones or cholecystectomy.
The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspectedinfection, hepatitis B or C, or cancer) that, in the investigator's opinion, wouldexpose them to undue risk of a significant adverse event (AE) or interfere withassessments of safety or efficacy during the course of the trial
Study Design
Connect with a study center
Xenoscience, Inc
Phoenix, Arizona 85004
United StatesSite Not Available
Xenoscience, Inc.
Phoenix, Arizona 85004
United StatesActive - Recruiting
Tucson Neuroscience Research
Tucson, Arizona 85710
United StatesSite Not Available
Tuscon Neuroscience Research, LLC
Tucson, Arizona 85710
United StatesActive - Recruiting
Hope Clinical Research
Canoga Park, California 91303
United StatesSite Not Available
Axiom Research, Llc
Colton, California 92324
United StatesSite Not Available
WR-PRI Encino
Encino, California 91316
United StatesActive - Recruiting
Wr-Pri, Llc
Encino, California 91316
United StatesSite Not Available
Velocity Clinical Research
La Mesa, California 91942
United StatesActive - Recruiting
eStudySite
La Mesa, California 91942
United StatesSite Not Available
Synergy San Diego
Lemon Grove, California 91945
United StatesSite Not Available
CNS Research
Long Beach, California 90806
United StatesSite Not Available
Collaborative Neuroscience Research, LLC.
Long Beach, California 90806
United StatesSite Not Available
CNS Research
Los Alamitos, California 90720
United StatesSite Not Available
Clinical Research Institute
Los Angeles, California 90048
United StatesSite Not Available
Pharmacology Research Institute / WR-PRI, LLC
Newport Beach, California 92660
United StatesSite Not Available
Wr-Pri, Llc
Newport Beach, California 92660
United StatesSite Not Available
Artemis Institute for Clinical Research
San Diego, California 92103
United StatesSite Not Available
California Neuroscience Research Med. Group, Inc.
Sherman Oaks, California 91403
United StatesActive - Recruiting
California Neuroscience Research Medical Group, inc.
Sherman Oaks, California 91403
United StatesSite Not Available
CMR of Greater New Haven, LLC
Hamden, Connecticut 06517
United StatesSite Not Available
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut 06905
United StatesSite Not Available
Chase Medical Research, LLC
Waterbury, Connecticut 06708
United StatesSite Not Available
Neurology Offices of South Florida
Boca Raton, Florida 33428
United StatesSite Not Available
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida 32132
United StatesSite Not Available
Complete Health Research
Edgewater, Florida 32132
United StatesSite Not Available
Sarkis Clinical Trials
Gainesville, Florida 32607
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256
United StatesSite Not Available
Multi-Specialty Research Associates, Inc.
Lake City, Florida 32055
United StatesSite Not Available
AppleMed Research Group, LLC
Miami, Florida 33126
United StatesSite Not Available
Brainstorm Research
Miami, Florida 33176
United StatesSite Not Available
The Neurology Research Group
Miami, Florida 33176
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida 32801
United StatesActive - Recruiting
Complete Health Research
Ormond Beach, Florida 32174
United StatesSite Not Available
Ideal Clinical Research
Pembroke, Florida 33026
United StatesSite Not Available
Ideal Clinical Research
Pembroke Pines, Florida 33026
United StatesSite Not Available
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United StatesSite Not Available
Accel Research Sites Network - St. Petersburg Clinical Research Unit
Saint Petersburg, Florida 33709
United StatesSite Not Available
Accel Research Site
Seminole, Florida 33777
United StatesSite Not Available
Clin-Med Research & Development LLC
South Miami, Florida 33143
United StatesSite Not Available
Clin-Med Research & Development, Llc
South Miami, Florida 33143
United StatesActive - Recruiting
ForCare Clinical Research
Tampa, Florida 33613
United StatesSite Not Available
JSV Clinical Research Study Inc
Tampa, Florida 33634
United StatesSite Not Available
JSV Clinical Researh Study, Inc.
Tampa, Florida 33634
United StatesActive - Recruiting
CenExel iResearch, LLC
Decatur, Georgia 30030
United StatesSite Not Available
iResearch Atlanta LLC
Decatur, Georgia 30030
United StatesSite Not Available
Cedar Crosse Research Center
Chicago, Illinois 60607
United StatesSite Not Available
Clinical Investigation Specialists, Inc
Gurnee, Illinois 60031
United StatesSite Not Available
Clinical Investigation Specialists, Inc.
Gurnee, Illinois 60031
United StatesSite Not Available
MediSphere Medical Research Center, LLC
Evansville, Indiana 47714
United StatesSite Not Available
MediSphere Medical Research Center, LLC.
Evansville, Indiana 47714
United StatesSite Not Available
Meridian Clinical Research
Sioux City, Iowa 51106
United StatesActive - Recruiting
Meridian Clinical Research, LLC
Sioux City, Iowa 51106
United StatesSite Not Available
Alliance for Multispecialty Reseach, LLC
El Dorado, Kansas 67042
United StatesSite Not Available
Alliance for Multispecialty Research, LLC.
El Dorado, Kansas 67042
United StatesTerminated
Alliance for Multispecialty Research, LLC
Newton, Kansas 67114
United StatesSite Not Available
Alliance for Multispecialty Research, LLC.
Newton, Kansas 67114
United StatesTerminated
Collective Medical Research
Overland Park, Kansas 66210
United StatesActive - Recruiting
Collevtive Medical Research
Overland Park, Kansas 66210
United StatesSite Not Available
Kansas Institute of Research
Overland Park, Kansas 66211
United StatesSite Not Available
Collective Medical Research
Prairie Village, Kansas 66208
United StatesSite Not Available
Alliance for Multispecialty Research, LLC.
Wichita, Kansas 67205
United StatesSite Not Available
The Research Group of Lexington, Llc
Lexington, Kentucky 40503
United StatesSite Not Available
The Research Group of Lexington, Llc.
Lexington, Kentucky 40503
United StatesSite Not Available
L-MARC Research Center
Louisville, Kentucky 40213
United StatesSite Not Available
Crescent City Headache and Neurology
Chalmette, Louisiana 70043
United StatesActive - Recruiting
Crescent City Headache and Neurology Center
Chalmette, Louisiana 70043
United StatesSite Not Available
AMR New Orleans
New Orleans, Louisiana 70119
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC.
New Orleans, Louisiana 70119
United StatesSite Not Available
DelRicht Research
New Orleans, Louisiana 70124
United StatesSite Not Available
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesSite Not Available
Neurology Center of New England P.C.
Foxboro, Massachusetts 02035
United StatesSite Not Available
Neurology Center of New England, P.C.
Foxboro, Massachusetts 02035
United StatesActive - Recruiting
Community Clinical Research Netword
Marlborough, Massachusetts 01752
United StatesActive - Recruiting
Community Clinical Research Network Inc
Marlborough, Massachusetts 01752
United StatesSite Not Available
MedVadis Research Corporation
Waltham, Massachusetts 02451
United StatesSite Not Available
Medvadis Research Coroporation
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan 48104
United StatesSite Not Available
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104
United StatesActive - Recruiting
Romedica LLC
Rochester, Michigan 48307
United StatesSite Not Available
Romedica, LLC
Rochester, Michigan 48307
United StatesTerminated
Clinical Resarch Institiute, Inc.
Minneapolis, Minnesota 55402
United StatesSite Not Available
Alliance for Multispecialty Reseach, LLC
Kansas City, Missouri 64114
United StatesSite Not Available
Alliance for Multispecialty Research, LLC.
Kansas City, Missouri 64114
United StatesActive - Recruiting
StudyMetrix Research
Saint Peters, Missouri 63303
United StatesSite Not Available
Clinvest Research, LLC
Springfield, Missouri 65807
United StatesSite Not Available
Clinvest Research, LLC.
Springfield, Missouri 65810
United StatesActive - Recruiting
Meridian Clinical Research
Norfolk, Nebraska 68701
United StatesActive - Recruiting
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701
United StatesSite Not Available
Excel Clinical research
Las Vegas, Nevada 89109
United StatesSite Not Available
Wr-Crcn, Llc
Las Vegas, Nevada 89118
United StatesSite Not Available
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102
United StatesSite Not Available
Dent Neurosciences Research Center
Amherst, New York 14226
United StatesActive - Recruiting
Dent Neurosciences Research Center, Inc.
Amherst, New York 14226
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
Montefiore Medical Center: Headache Center
Bronx, New York 10461
United StatesActive - Recruiting
Central New York Clinical Research
Manlius, New York 13104
United StatesSite Not Available
Fieve Clinical Research, Inc
New York, New York 10017
United StatesSite Not Available
Fieve Clinical Research, Inc.
New York, New York 10017
United StatesActive - Recruiting
New York Neurology Associates
New York, New York 10003
United StatesSite Not Available
North Suffolk Neurology
Port Jefferson Station, New York 11776
United StatesActive - Recruiting
North Suffolk Neurology, PC
Port Jefferson Station, New York 11776
United StatesSite Not Available
Upstate Clinical Research Associates, LLC
Williamsville, New York 14221
United StatesSite Not Available
Headache Wellness Center
Greensboro, North Carolina 27405
United StatesSite Not Available
Accellacare
Raleigh, North Carolina 27609
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesSite Not Available
PMG Research of Raleigh, LLC
Raleigh, North Carolina 27609
United StatesActive - Recruiting
Wake Research Associates, LLC
Raleigh, North Carolina 27612
United StatesSite Not Available
Carolina Research Center, Inc.
Shelby, North Carolina 28150
United StatesSite Not Available
Accellacare
Wilmington, North Carolina 28401
United StatesSite Not Available
PMG Research of Wilmington
Wilmington, North Carolina 28411
United StatesActive - Recruiting
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesSite Not Available
WellNow Urgent Care and Research
Cincinnati, Ohio 45215
United StatesSite Not Available
Wellnow Urgent Care
Cincinnati, Ohio 45215
United StatesSite Not Available
Hometown Urgent Care and Research
Columbus, Ohio 43214
United StatesSite Not Available
Hometown Urgent Care and Research-Clintonville
Columbus, Ohio 43214
United StatesSite Not Available
Wellnow Urgent Care and Research
Columbus, Ohio 43214
United StatesSite Not Available
Hometown Urgent Care and Research
Dayton, Ohio 45424
United StatesSite Not Available
Hometown Urgent Care of Michigan P.C. d/b/a WellNow Urgent Care and Research
Dayton, Ohio 45424
United StatesActive - Recruiting
WellNow Urgent Care and Research
Dayton, Ohio 45424
United StatesSite Not Available
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio 44720
United StatesSite Not Available
Neuro-Behavuoral Clinical Research, Inc.
North Canton, Ohio 44720
United StatesActive - Recruiting
Hometown Urgent Care of Michigan P.C. d/b/a WellNow Urgent Care and Research
Troy, Ohio 45373
United StatesActive - Recruiting
WellNow Urgent Care and Research
Troy, Ohio 45373
United StatesSite Not Available
Hightower Clinical
Oklahoma City, Oklahoma 73102
United StatesSite Not Available
Summit Headlands LLC, dba Summit Research
Portland, Oregon 97210
United StatesSite Not Available
Summit Research Network (Oregon) Inc.
Portland, Oregon 97210
United StatesActive - Recruiting
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania 15236
United StatesSite Not Available
Perferred Primary Care Physicians
Uniontown, Pennsylvania 15401
United StatesActive - Recruiting
Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Reading Hospital Clinical Trials Office
West Reading, Pennsylvania 19611
United StatesSite Not Available
Tower Health Medical Group - Neurology
West Reading, Pennsylvania 19611
United StatesSite Not Available
Coastal Carolina Research Center
North Charleston, South Carolina 29405
United StatesSite Not Available
Accellacare (Administrative Only)
Bristol, Tennessee 37620
United StatesSite Not Available
Accellacare of Bristol
Bristol, Tennessee 37620
United StatesActive - Recruiting
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee 37620
United StatesSite Not Available
WR-ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
KCA Neurology
Franklin, Tennessee 37067
United StatesActive - Recruiting
KCA Neurology, PLLC
Franklin, Tennessee 37067
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
FuturSearch Trials of Neurology
Austin, Texas 78731
United StatesActive - Recruiting
FutureSearch Trials of Neurology
Austin, Texas 78731
United StatesSite Not Available
FutureSearch Trials of Dallas, LP
Dallas, Texas 75231
United StatesSite Not Available
North Texas Institute of Neurology and Headache
Frisco, Texas 75034
United StatesSite Not Available
North Texas Institute of Neurology and Headache - NextStage Clinical Research
Frisco, Texas 75034
United StatesSite Not Available
Texas Center for Drug Development, Inc.
Houston, Texas 77081
United StatesSite Not Available
Red Star Research, LLC.
Lake Jackson, Texas 77566
United StatesActive - Recruiting
Red Star Research. LLC
Lake Jackson, Texas 77566
United StatesSite Not Available
FMC Science
Lampasas, Texas 76550
United StatesSite Not Available
FMC Science LLC
Lampasas, Texas 76550
United StatesActive - Recruiting
Radiance Clinical Research
Lampasas, Texas 76550
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesSite Not Available
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah 84107
United StatesSite Not Available
Wasatch Clinical Research, LLC
Salt Lake City, Utah 84107
United StatesActive - Recruiting
Charlottesville Medical Research
Charlottesville, Virginia 22911
United StatesActive - Recruiting
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia 22911
United StatesSite Not Available
Health Research of Hampton Roads, Inc.
Newport News, Virginia 23606
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
Seattle CRC, LLC DBA Seattle Clinical Research Center
Seattle, Washington 98105
United StatesActive - Recruiting
Seattle Clinical Research Center
Seattle, Washington 98105
United StatesSite Not Available
Seattle Women's: Health, Research, Gynecology
Seattle, Washington 98105
United StatesSite Not Available
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