Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2015
End Date:August 2016

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A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

This is a prospective randomized, double-blind, placebo-controlled study in subjects with
disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Subjects will be asked to treat a migraine attack with study drug on an outpatient basis.
Subjects will be provided with a dosing card containing a dose for initial treatment and a
second dose to be used for rescue or recurrence of migraine. Each subject's study
participation will consist of a screening visit (Visit 1) with a telephone contact within 7
days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS)
visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time
on study is approximately 11 weeks.

Inclusion Criteria:

- Able and willing to give written informed consent.

- Patients with migraine with or without aura fulfilling the International Headache
Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification
(ICHD) 2004).

- History of disabling migraine for at least 1 year.

- MIDAS score ≥11.

- Migraine onset before the age of 50 years.

- History of 3 - 8 migraine attacks per month (< 15 headache days per month).

- Male or female, aged 18 years or above.

- Females of child-bearing potential must be using or willing to use a highly effective
form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD),
abstinence or vasectomized partner).

- Able and willing to complete an electronic diary.

Exclusion Criteria:

- Pregnant or breast-feeding women.

- Women of child-bearing potential not using or not willing to use highly effective
contraception.

- Known coronary artery disease, clinically significant arrhythmia or uncontrolled
hypertension.

- History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the
subject at increased risk of seizures.

- History of recurrent dizziness and/or vertigo including benign paroxysmal positional
vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular
disorders.

- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or
neuropathy).

- History within the previous three years or current evidence of abuse of any drug,
prescription or illicit, or alcohol.

- History of orthostatic hypotension with syncope.

- Significant renal or hepatic impairment.

- Subject is at imminent risk of suicide (positive response to question 4 or 5 on the
C-SSRS) or had a suicide attempt within six months prior to the screening visit.

- Known Hepatitis B or C or HIV infection.

- History, within past 12 months, of chronic migraine or other forms of primary or
secondary chronic headache disorder (e.g. hemicranias continua, medication overuse
headache) where headache frequency is greater than 15 headache days per month.

- Use of more than 3 doses per month of either opiates or barbiturates.

- Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes within three (3) months prior to Screening/Visit 1.
We found this trial at
92
sites
Birmingham, Alabama 35205
Principal Investigator: M. Han, MD
2080
mi
from 98109
Birmingham, AL
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Principal Investigator: H. Williams, MD
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
2084
mi
from 98109
Birmingham, AL
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
Principal Investigator: P. K. Brownstone, MD
996
mi
from 98109
Boulder, CO
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
Principal Investigator: K. Wilks, MD
2723
mi
from 98109
Hallandale Beach, FL
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
Principal Investigator: C Alftine, MD
368
mi
from 98109
Medford, OR
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: M. Kutner, MD
2730
mi
from 98109
Miami, FL
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Akron, Ohio 44311
Principal Investigator: J Klein, MD
2042
mi
from 98109
Akron, OH
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Allen, Texas 75013
Principal Investigator: J. Stewart, MD
1670
mi
from 98109
Allen, TX
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Anderson, South Carolina 29621
Principal Investigator: H Geisberg, MD
2227
mi
from 98109
Anderson, SC
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Anderson, South Carolina 29621
Principal Investigator: J Kopp, MD
2227
mi
from 98109
Anderson, SC
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Atlanta, Georgia
Principal Investigator: B Davis, MD
2178
mi
from 98109
Atlanta, GA
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Aurora, Colorado 80014
Principal Investigator: M Lewis, MD
1027
mi
from 98109
Aurora, CO
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Austin, Texas 78735
Principal Investigator: M. Dawson, MD
1766
mi
from 98109
Austin, TX
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Birmingham, Alabama 35211
Principal Investigator: W Kirby, MD
2078
mi
from 98109
Birmingham, AL
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Boise, Idaho 83704
Principal Investigator: B. McConnehey, DO
402
mi
from 98109
Boise, ID
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Boston, Massachusetts 02135
Principal Investigator: A. Stolyar, MD
2485
mi
from 98109
Boston, MA
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Bridgeton, Missouri 63044
Principal Investigator: N Razzaque, MD
1704
mi
from 98109
Bridgeton, MO
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Brooksville, Florida
Principal Investigator: K. Maw, MD
2501
mi
from 98109
Brooksville, FL
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Carlsbad, California 92008
Principal Investigator: G Korff, MD
1035
mi
from 98109
Carlsbad, CA
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Chandler, Arizona 85224
Principal Investigator: D DeSantis, MD
1131
mi
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Chandler, AZ
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Chandler, Arizona 85225
Principal Investigator: R Severance, MD
1130
mi
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Chandler, AZ
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Chandler, Arizona 85224
Principal Investigator: M Turner, MD
1128
mi
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Chandler, AZ
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Charleston, South Carolina 29407
Principal Investigator: D Hurley, MD
2419
mi
from 98109
Charleston, SC
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Chicago, Illinois 60604
Principal Investigator: L Hiotis, MD
1733
mi
from 98109
Chicago, IL
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Chicago, Illinois 60631
Principal Investigator: T Jagielo, MD
1733
mi
from 98109
Chicago, IL
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Chicago, Illinois 60654
Principal Investigator: J Lentino, MD
1732
mi
from 98109
Chicago, IL
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Cincinnati, Ohio 45249
1970
mi
from 98109
Cincinnati, OH
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Cleveland, Ohio 44122
Principal Investigator: H. Dushkin, MD
2029
mi
from 98109
Cleveland, OH
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Colorado Springs, Colorado 80909
Principal Investigator: D. Bird, MD
1067
mi
from 98109
Colorado Springs, CO
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Columbus, Ohio 43212
Principal Investigator: D Schumacher, MD
2005
mi
from 98109
Columbus, OH
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Council Bluffs, Iowa 51503
Principal Investigator: J Kay, MD
1373
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Council Bluffs, IA
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Dallas, Texas 75231
Principal Investigator: M Reynolds, MD
1678
mi
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Dallas, TX
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Edina, Minnesota 55435
Principal Investigator: L Kotek, MD
1390
mi
from 98109
Edina, MN
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Edmond, Oklahoma 73034
Principal Investigator: R Conrady, MD
1517
mi
from 98109
Edmond, OK
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Elkhorn, Nebraska 68022
Principal Investigator: W Fitzgibbons, MD
1352
mi
from 98109
Elkhorn, NE
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Evanston, Illinois 60201
Principal Investigator: J. Geohas, MD
1725
mi
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Evanston, IL
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Evansville, Indiana 47714
Principal Investigator: M Allaw, MD
1865
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Evansville, IN
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Evansville, Indiana 47725
Principal Investigator: A Inzerello, MD
1866
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Evansville, IN
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Fountain Hills, Arizona 85268
Principal Investigator: M. Hummel, MD
1115
mi
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Fountain Hills, AZ
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Fremont, Nebraska 68025
Principal Investigator: T Wolf, MD
1335
mi
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Fremont, NE
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Gilbert, Arizona 85234
Principal Investigator: W Grainger, MD
1129
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Gilbert, AZ
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Glendale, Arizona 85306
Principal Investigator: N Godbole, MD
1107
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Glendale, AZ
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Glendale, Arizona 85308
Principal Investigator: T Lenzmeier, MD
1099
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Glendale, AZ
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Gold River, California 95670
Principal Investigator: M. Palatnik, MD
624
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Gold River, CA
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Greer, South Carolina
Principal Investigator: W Ellison, MD
2229
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Greer, SC
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Henderson, Nevada 89014
Principal Investigator: J Mell, DO
885
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Henderson, NV
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Henderson, Nevada 89052
Principal Investigator: R Chuang, MD
885
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Henderson, NV
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Henderson, Nevada 89074
Principal Investigator: I Fakhouri, MD
883
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Henderson, NV
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Jamaica, New York 11432
Principal Investigator: A Vallanat, MD
2412
mi
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Jamaica, NY
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Kansas City, Missouri 64114
Principal Investigator: J. Ervin, MD
1507
mi
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Kansas City, MO
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Knoxville, Tennessee 37920
Principal Investigator: W. Smith, MD
2113
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Knoxville, TN
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Las Vegas, Nevada 89118
Principal Investigator: D Burke, MD
877
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Las Vegas, NV
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Las Vegas, Nevada 89118
877
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Las Vegas, Nevada 89128
Principal Investigator: C Molin, MD
873
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Las Vegas, NV
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Marietta, Georgia 30067
Principal Investigator: C Davis, MD
2167
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Marietta, GA
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Meridian, Idaho 83642
Principal Investigator: M. Turner, MD
399
mi
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Meridian, ID
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Mesa, Arizona 85206
Principal Investigator: T Bruce, MD
1124
mi
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Mesa, Arizona 85201
Principal Investigator: G Shockey, MD
1123
mi
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Mesa, AZ
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Midwest City, Oklahoma 73110
Principal Investigator: W Willliams, MD
1529
mi
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Midwest City, OK
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Murray, Utah 84123
Principal Investigator: M Adams, MD
705
mi
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Murray, UT
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Norman, Oklahoma 73069
Principal Investigator: L. Connery, MD
1538
mi
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Norman, OK
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Oklahoma City, Oklahoma 73104
Principal Investigator: C Lunn, MD
1523
mi
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Oklahoma City, OK
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: C. Griffin, MD
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
1523
mi
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Oklahoma City, OK
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Omaha, Nebraska 68124
Principal Investigator: J Titus, MD
1362
mi
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Omaha, NE
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Orlando, Florida 32806
Principal Investigator: R. Molpus, MD
2549
mi
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Orlando, FL
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Overland Park, Kansas 66210
Principal Investigator: A. Khalifa, MD
1503
mi
from 98109
Overland Park, KS
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: S. Silberstein, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
2373
mi
from 98109
Philadelphia, PA
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Phoenix, Arizona 85018
Principal Investigator: D Francyk, MD
1116
mi
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Phoenix, AZ
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Phoenix, Arizona 85020
Principal Investigator: E Riffer, MD
1116
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Phoenix, Arizona 85037
Principal Investigator: D Schlosser, MD
1109
mi
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Phoenix, AZ
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Phoenix, Arizona 85050
Principal Investigator: P Levins, MD
1104
mi
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Phoenix, AZ
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Pinellas Park, Florida 33781
Principal Investigator: L Murray, MD
2521
mi
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Pinellas Park, FL
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Plano, Texas 75024
Principal Investigator: M Ampajwala, MD
1665
mi
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Plano, TX
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Plano, Texas 75093
Principal Investigator: L Baktari, MD
1667
mi
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Plano, TX
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Plano, Texas 75093
Principal Investigator: S Glep, MD
1673
mi
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Plano, TX
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Portland, Oregon 97210
Principal Investigator: B. Essink, MD
146
mi
from 98109
Portland, OR
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Saint Louis, Missouri 63151
1721
mi
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Saint Louis, MO
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San Antonio, Texas
Principal Investigator: W Jennings, MD
1787
mi
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San Antonio, TX
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San Diego, California 92123
Principal Investigator: V. Mehra, MD
1060
mi
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San Diego, CA
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Santa Rosa, California 95405
Principal Investigator: S Halpern, MD
635
mi
from 98109
Santa Rosa, CA
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Scottsdale, Arizona 85251
Principal Investigator: A Tejada, MD
1117
mi
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Scottsdale, AZ
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Sunrise, Florida 33351
Principal Investigator: R Singer, MD
2708
mi
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Sunrise, FL
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Suwanee, Georgia 30024
Principal Investigator: D. Lesch, MD
2180
mi
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Suwanee, GA
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Tampa, Florida
Principal Investigator: C. Huffman, MD
2527
mi
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Tampa, FL
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Tempe, Arizona 85283
Principal Investigator: T Fiel, MD
1122
mi
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Tempe, AZ
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Tucson, Arizona 85712
Principal Investigator: R Lending, MD
1220
mi
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Tucson, AZ
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Tucson, Arizona 85741
Principal Investigator: J Brown, MD
1212
mi
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Tucson, AZ
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Vista, California 92083
Principal Investigator: K Bhasker, MD
1031
mi
from 98109
Vista, CA
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Warwick, Rhode Island 02886
Principal Investigator: S. Verma, MD
2487
mi
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Warwick, RI
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Washington, District of Columbia 20016
Principal Investigator: A Lowy, MD
2318
mi
from 98109
Washington,
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Wichita, Kansas 67205
Principal Investigator: T. Klein, MD
1435
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Wichita, KS
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Wichita, Kansas 67205
1435
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