A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

Last updated: March 25, 2025
Sponsor: Pfizer
Overall Status: Terminated

Phase

2/3

Condition

Chronic Pain

Oral Facial Pain

Pain (Pediatric)

Treatment

Placebo

BHV-3500 (zavegepant)

Clinical Study ID

NCT04804033
BHV3500-302
C5301006
  • Ages > 18
  • All Genders

Study Summary

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

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:

  1. Age of onset of migraines prior to 50 years of age

  2. Migraine attacks, on average, lasting 4 - 72 hours if untreated

  3. 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

  4. Eight or more migraine days during the Observation Period

  5. 15 or more headache days during the Observation Period

  6. One or more non-headache days during the Observation Period

  7. Ability to distinguish migraine attacks from tension/cluster headaches

  8. 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:

  1. Subject with a history of HIV disease

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. Body mass index > 33 kg/m2

  8. History of gallstones or cholecystectomy.

  9. 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

Total Participants: 1753
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
March 26, 2021
Estimated Completion Date:
March 21, 2024

Connect with a study center

  • Xenoscience, Inc

    Phoenix, Arizona 85004
    United States

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  • Xenoscience, Inc.

    Phoenix, Arizona 85004
    United States

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  • Tucson Neuroscience Research

    Tucson, Arizona 85710
    United States

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  • Tuscon Neuroscience Research, LLC

    Tucson, Arizona 85710
    United States

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  • Hope Clinical Research

    Canoga Park, California 91303
    United States

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  • Axiom Research, Llc

    Colton, California 92324
    United States

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  • WR-PRI Encino

    Encino, California 91316
    United States

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  • Wr-Pri, Llc

    Encino, California 91316
    United States

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  • Velocity Clinical Research

    La Mesa, California 91942
    United States

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  • eStudySite

    La Mesa, California 91942
    United States

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  • Synergy San Diego

    Lemon Grove, California 91945
    United States

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  • CNS Research

    Long Beach, California 90806
    United States

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  • Collaborative Neuroscience Research, LLC.

    Long Beach, California 90806
    United States

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  • CNS Research

    Los Alamitos, California 90720
    United States

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  • Clinical Research Institute

    Los Angeles, California 90048
    United States

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  • Pharmacology Research Institute / WR-PRI, LLC

    Newport Beach, California 92660
    United States

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  • Wr-Pri, Llc

    Newport Beach, California 92660
    United States

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  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

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  • California Neuroscience Research Med. Group, Inc.

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • California Neuroscience Research Medical Group, inc.

    Sherman Oaks, California 91403
    United States

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  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

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  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

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  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

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  • Neurology Offices of South Florida

    Boca Raton, Florida 33428
    United States

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  • Accel Research Sites Network - Edgewater Clinical Research Unit

    Edgewater, Florida 32132
    United States

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  • Complete Health Research

    Edgewater, Florida 32132
    United States

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  • Sarkis Clinical Trials

    Gainesville, Florida 32607
    United States

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  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

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  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida 32055
    United States

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    Miami, Florida 33126
    United States

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  • Brainstorm Research

    Miami, Florida 33176
    United States

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  • The Neurology Research Group

    Miami, Florida 33176
    United States

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  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

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  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Orlando, Florida 32801
    United States

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  • Complete Health Research

    Ormond Beach, Florida 32174
    United States

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    Pembroke, Florida 33026
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    Pembroke Pines, Florida 33026
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    Pompano Beach, Florida 33060
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    Saint Petersburg, Florida 33709
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    Seminole, Florida 33777
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    South Miami, Florida 33143
    United States

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    South Miami, Florida 33143
    United States

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  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

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    Tampa, Florida 33634
    United States

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    Tampa, Florida 33634
    United States

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  • CenExel iResearch, LLC

    Decatur, Georgia 30030
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    Decatur, Georgia 30030
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    Chicago, Illinois 60607
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  • Clinical Investigation Specialists, Inc

    Gurnee, Illinois 60031
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    Gurnee, Illinois 60031
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  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
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    Evansville, Indiana 47714
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    Sioux City, Iowa 51106
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    Sioux City, Iowa 51106
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  • Alliance for Multispecialty Reseach, LLC

    El Dorado, Kansas 67042
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    El Dorado, Kansas 67042
    United States

    Terminated

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas 67114
    United States

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    Newton, Kansas 67114
    United States

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    Overland Park, Kansas 66210
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    Overland Park, Kansas 66210
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    Prairie Village, Kansas 66208
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    Wichita, Kansas 67205
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    Lexington, Kentucky 40503
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    Lexington, Kentucky 40503
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    Louisville, Kentucky 40213
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    Chalmette, Louisiana 70043
    United States

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    Chalmette, Louisiana 70043
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    New Orleans, Louisiana 70119
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    New Orleans, Louisiana 70124
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    Foxboro, Massachusetts 02035
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    Waltham, Massachusetts 02451
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    Ann Arbor, Michigan 48104
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    Ann Arbor, Michigan 48104
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  • Romedica LLC

    Rochester, Michigan 48307
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    Rochester, Michigan 48307
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    Minneapolis, Minnesota 55402
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    Kansas City, Missouri 64114
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    Norfolk, Nebraska 68701
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    Norfolk, Nebraska 68701
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    Las Vegas, Nevada 89109
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    Las Vegas, Nevada 89118
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    Albuquerque, New Mexico 87102
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  • Dent Neurosciences Research Center

    Amherst, New York 14226
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    Amherst, New York 14226
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  • Montefiore Medical Center

    Bronx, New York 10461
    United States

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  • Montefiore Medical Center: Headache Center

    Bronx, New York 10461
    United States

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  • Central New York Clinical Research

    Manlius, New York 13104
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    New York, New York 10017
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    New York, New York 10017
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    New York, New York 10003
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    Port Jefferson Station, New York 11776
    United States

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  • North Suffolk Neurology, PC

    Port Jefferson Station, New York 11776
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  • Upstate Clinical Research Associates, LLC

    Williamsville, New York 14221
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  • Headache Wellness Center

    Greensboro, North Carolina 27405
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    Raleigh, North Carolina 27609
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    Raleigh, North Carolina 27612
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    Raleigh, North Carolina 27609
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    Shelby, North Carolina 28150
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    Wilmington, North Carolina 28401
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    Wilmington, North Carolina 28411
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    Cincinnati, Ohio 45212
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  • WellNow Urgent Care and Research

    Cincinnati, Ohio 45215
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    Cincinnati, Ohio 45215
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    Columbus, Ohio 43214
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    Columbus, Ohio 43214
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    Columbus, Ohio 43214
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    Dayton, Ohio 45424
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    Dayton, Ohio 45424
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  • WellNow Urgent Care and Research

    Dayton, Ohio 45424
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  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio 44720
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    North Canton, Ohio 44720
    United States

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  • Hometown Urgent Care of Michigan P.C. d/b/a WellNow Urgent Care and Research

    Troy, Ohio 45373
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    Troy, Ohio 45373
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    Oklahoma City, Oklahoma 73102
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  • Summit Headlands LLC, dba Summit Research

    Portland, Oregon 97210
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    Portland, Oregon 97210
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  • Clinical Research Philadelphia, LLC

    Philadelphia, Pennsylvania 19114
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  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania 15236
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    Uniontown, Pennsylvania 15401
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  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
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  • Reading Hospital Clinical Trials Office

    West Reading, Pennsylvania 19611
    United States

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  • Tower Health Medical Group - Neurology

    West Reading, Pennsylvania 19611
    United States

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  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

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  • Accellacare (Administrative Only)

    Bristol, Tennessee 37620
    United States

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  • Accellacare of Bristol

    Bristol, Tennessee 37620
    United States

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  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee 37620
    United States

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    Chattanooga, Tennessee 37421
    United States

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  • KCA Neurology

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • KCA Neurology, PLLC

    Franklin, Tennessee 37067
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  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
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  • FuturSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas 75231
    United States

    Site Not Available

  • North Texas Institute of Neurology and Headache

    Frisco, Texas 75034
    United States

    Site Not Available

  • North Texas Institute of Neurology and Headache - NextStage Clinical Research

    Frisco, Texas 75034
    United States

    Site Not Available

  • Texas Center for Drug Development, Inc.

    Houston, Texas 77081
    United States

    Site Not Available

  • Red Star Research, LLC.

    Lake Jackson, Texas 77566
    United States

    Active - Recruiting

  • Red Star Research. LLC

    Lake Jackson, Texas 77566
    United States

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  • FMC Science

    Lampasas, Texas 76550
    United States

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  • FMC Science LLC

    Lampasas, Texas 76550
    United States

    Active - Recruiting

  • Radiance Clinical Research

    Lampasas, Texas 76550
    United States

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    Tomball, Texas 77375
    United States

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  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City, Utah 84107
    United States

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  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Active - Recruiting

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

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  • Seattle CRC, LLC DBA Seattle Clinical Research Center

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington 98105
    United States

    Site Not Available

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