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

Use our guide to learn which trials are right for you!

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
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
Principal Investigator: K. Wilks, MD
1313
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
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...
687
mi
from
Birmingham, AL
Click here to add this to my saved trials
1000 Alpine
Boulder, Colorado 80304
303-443-7229
Principal Investigator: P. K. Brownstone, MD
430
mi
from
Boulder, CO
Click here to add this to my saved trials
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
Principal Investigator: C Alftine, MD
1355
mi
from
Medford, OR
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: M. Kutner, MD
1319
mi
from
Miami, FL
Click here to add this to my saved trials
Akron, Ohio 44311
Principal Investigator: J Klein, MD
898
mi
from
Akron, OH
Click here to add this to my saved trials
Allen, Texas 75013
Principal Investigator: J. Stewart, MD
327
mi
from
Allen, TX
Click here to add this to my saved trials
Anderson, South Carolina 29621
Principal Investigator: H Geisberg, MD
874
mi
from
Anderson, SC
Click here to add this to my saved trials
Anderson, South Carolina 29621
Principal Investigator: J Kopp, MD
874
mi
from
Anderson, SC
Click here to add this to my saved trials
Atlanta, Georgia
Principal Investigator: B Davis, MD
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80014
Principal Investigator: M Lewis, MD
401
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78735
Principal Investigator: M. Dawson, MD
517
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35205
Principal Investigator: M. Han, MD
684
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35211
Principal Investigator: W Kirby, MD
682
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83704
Principal Investigator: B. McConnehey, DO
1046
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02135
Principal Investigator: A. Stolyar, MD
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeton, Missouri 63044
Principal Investigator: N Razzaque, MD
406
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Brooksville, Florida
Principal Investigator: K. Maw, MD
1093
mi
from
Brooksville, FL
Click here to add this to my saved trials
Carlsbad, California 92008
Principal Investigator: G Korff, MD
1140
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Chandler, Arizona 85224
Principal Investigator: D DeSantis, MD
844
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85225
Principal Investigator: R Severance, MD
844
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
Principal Investigator: M Turner, MD
846
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29407
Principal Investigator: D Hurley, MD
1059
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60604
Principal Investigator: L Hiotis, MD
609
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60631
Principal Investigator: T Jagielo, MD
609
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60654
Principal Investigator: J Lentino, MD
610
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45249
736
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
Principal Investigator: H. Dushkin, MD
903
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
Principal Investigator: D. Bird, MD
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Ohio 43212
Principal Investigator: D Schumacher, MD
808
mi
from
Columbus, OH
Click here to add this to my saved trials
Council Bluffs, Iowa 51503
Principal Investigator: J Kay, MD
265
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: M Reynolds, MD
342
mi
from
Dallas, TX
Click here to add this to my saved trials
Edina, Minnesota 55435
Principal Investigator: L Kotek, MD
544
mi
from
Edina, MN
Click here to add this to my saved trials
Edmond, Oklahoma 73034
Principal Investigator: R Conrady, MD
146
mi
from
Edmond, OK
Click here to add this to my saved trials
Elkhorn, Nebraska 68022
Principal Investigator: W Fitzgibbons, MD
258
mi
from
Elkhorn, NE
Click here to add this to my saved trials
Evanston, Illinois 60201
Principal Investigator: J. Geohas, MD
613
mi
from
Evanston, IL
Click here to add this to my saved trials
Evansville, Indiana 47714
Principal Investigator: M Allaw, MD
559
mi
from
Evansville, IN
Click here to add this to my saved trials
Evansville, Indiana 47725
Principal Investigator: A Inzerello, MD
559
mi
from
Evansville, IN
Click here to add this to my saved trials
Fountain Hills, Arizona 85268
Principal Investigator: M. Hummel, MD
830
mi
from
Fountain Hills, AZ
Click here to add this to my saved trials
Fremont, Nebraska 68025
Principal Investigator: T Wolf, MD
263
mi
from
Fremont, NE
Click here to add this to my saved trials
Gilbert, Arizona 85234
Principal Investigator: W Grainger, MD
838
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glendale, Arizona 85306
Principal Investigator: N Godbole, MD
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
Glendale, Arizona 85308
Principal Investigator: T Lenzmeier, MD
853
mi
from
Glendale, AZ
Click here to add this to my saved trials
Gold River, California 95670
Principal Investigator: M. Palatnik, MD
1270
mi
from
Gold River, CA
Click here to add this to my saved trials
Greer, South Carolina
Principal Investigator: W Ellison, MD
888
mi
from
Greer, SC
Click here to add this to my saved trials
Henderson, Nevada 89014
Principal Investigator: J Mell, DO
954
mi
from
Henderson, NV
Click here to add this to my saved trials
Henderson, Nevada 89052
Principal Investigator: R Chuang, MD
954
mi
from
Henderson, NV
Click here to add this to my saved trials
Henderson, Nevada 89074
Principal Investigator: I Fakhouri, MD
959
mi
from
Henderson, NV
Click here to add this to my saved trials
Jamaica, New York 11432
Principal Investigator: A Vallanat, MD
1297
mi
from
Jamaica, NY
Click here to add this to my saved trials
Kansas City, Missouri 64114
Principal Investigator: J. Ervin, MD
193
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37920
Principal Investigator: W. Smith, MD
779
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89118
Principal Investigator: D Burke, MD
966
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89118
966
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Principal Investigator: C Molin, MD
960
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Marietta, Georgia 30067
Principal Investigator: C Davis, MD
791
mi
from
Marietta, GA
Click here to add this to my saved trials
Meridian, Idaho 83642
Principal Investigator: M. Turner, MD
1050
mi
from
Meridian, ID
Click here to add this to my saved trials
Mesa, Arizona 85206
Principal Investigator: T Bruce, MD
840
mi
from
Mesa, AZ
Click here to add this to my saved trials
Mesa, Arizona 85201
Principal Investigator: G Shockey, MD
841
mi
from
Mesa, AZ
Click here to add this to my saved trials
Midwest City, Oklahoma 73110
Principal Investigator: W Willliams, MD
160
mi
from
Midwest City, OK
Click here to add this to my saved trials
Murray, Utah 84123
Principal Investigator: M Adams, MD
780
mi
from
Murray, UT
Click here to add this to my saved trials
Norman, Oklahoma 73069
Principal Investigator: L. Connery, MD
175
mi
from
Norman, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Principal Investigator: C Lunn, MD
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
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...
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68124
Principal Investigator: J Titus, MD
258
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: R. Molpus, MD
1143
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66210
Principal Investigator: A. Khalifa, MD
190
mi
from
Overland Park, KS
Click here to add this to my saved trials
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,...
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85018
Principal Investigator: D Francyk, MD
845
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85020
Principal Investigator: E Riffer, MD
852
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85037
Principal Investigator: D Schlosser, MD
861
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85050
Principal Investigator: P Levins, MD
843
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pinellas Park, Florida 33781
Principal Investigator: L Murray, MD
1110
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Plano, Texas 75024
Principal Investigator: M Ampajwala, MD
327
mi
from
Plano, TX
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: L Baktari, MD
330
mi
from
Plano, TX
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: S Glep, MD
332
mi
from
Plano, TX
Click here to add this to my saved trials
Portland, Oregon 97210
Principal Investigator: B. Essink, MD
1385
mi
from
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri 63151
418
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas
Principal Investigator: W Jennings, MD
576
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
Principal Investigator: V. Mehra, MD
1139
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Rosa, California 95405
Principal Investigator: S Halpern, MD
1348
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
Principal Investigator: A Tejada, MD
843
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Sunrise, Florida 33351
Principal Investigator: R Singer, MD
1299
mi
from
Sunrise, FL
Click here to add this to my saved trials
Suwanee, Georgia 30024
Principal Investigator: D. Lesch, MD
809
mi
from
Suwanee, GA
Click here to add this to my saved trials
Tampa, Florida
Principal Investigator: C. Huffman, MD
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
Tempe, Arizona 85283
Principal Investigator: T Fiel, MD
845
mi
from
Tempe, AZ
Click here to add this to my saved trials
Tucson, Arizona 85712
Principal Investigator: R Lending, MD
830
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85741
Principal Investigator: J Brown, MD
834
mi
from
Tucson, AZ
Click here to add this to my saved trials
Vista, California 92083
Principal Investigator: K Bhasker, MD
1135
mi
from
Vista, CA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
Principal Investigator: S. Verma, MD
1421
mi
from
Warwick, RI
Click here to add this to my saved trials
Washington, District of Columbia 20016
Principal Investigator: A Lowy, MD
1124
mi
from
Washington,
Click here to add this to my saved trials
Wichita, Kansas 67205
Principal Investigator: T. Klein, MD
26
mi
from
Wichita, KS
Click here to add this to my saved trials
Wichita, Kansas 67205
26
mi
from
Wichita, KS
Click here to add this to my saved trials