Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
NCT ID: NCT02605174
Last Updated: 2019-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3005 participants
INTERVENTIONAL
2016-05-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Lasmiditan 50 milligram (mg)
Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Lasmiditan 50 mg
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
Lasmiditan 100 mg
Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Lasmiditan 100 mg
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
Lasmiditan 200 mg
Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Lasmiditan 200 mg
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Placebo
Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Placebo
Two placebo tablets to match lasmiditan doses.
Interventions
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Lasmiditan 50 mg
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
Lasmiditan 100 mg
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
Lasmiditan 200 mg
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Placebo
Two placebo tablets to match lasmiditan doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants 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.
* Migraine Disability Association (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 to record details of the migraine attack treated with study drug.
Exclusion Criteria
* Pregnant or breast-feeding women.
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
* History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant 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.
* Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
* Previous participation in this clinical trial.
* Participation in any clinical trial of an experimental drug or device in the previous 30 days.
* 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 ≥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.
* Participants who are employees of the sponsor.
* Relatives of, or staff directly reporting to, the Investigator.
18 Years
ALL
No
Sponsors
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CoLucid Pharmaceuticals
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc. - ARC
Huntsville, Alabama, United States
21st Century Neurology
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
The Research Center of Southern California
Carlsbad, California, United States
eStudySite
Chula Vista, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute, Newport Beach
Newport Beach, California, United States
Pacific Research Partners
Oakland, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Northern California Clinical Research Center
Redding, California, United States
Anderson Clinical Research
Redlands, California, United States
California Research Foundation
San Diego, California, United States
Neurological Research Institute
Santa Monica, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
Denver, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Nova Clinical Reseach, LLC
Bradenton, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Meridien Research
Brooksville, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
The Core Research
Doral, Florida, United States
Clinical Research West Coast
Fort Myers, Florida, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research
Maitland, Florida, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
Prestige Clinical Research Center, Inc.
Miami, Florida, United States
Floriday Medical Center and Research, Inc.
Miami, Florida, United States
Veritas Research Corporation
Miami Lakes, Florida, United States
Harmony Clinical Research Inc.
North Miami Beach, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Clinical Research Center, LLC
Royal Palm Beach, Florida, United States
Meridien Research, Inc.
St. Petersburg, Florida, United States
Meridian Clinical Research, LLC
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Harbin Clinic, LLC
Rome, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Associates in Neurology, P.S.C.
Lexington, Kentucky, United States
Research Integrity, LLC.
Owensboro, Kentucky, United States
New Orleans Center for Clinical Research, Inc.
New Orleans, Louisiana, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Adirondack Medical Research Center
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
PMG Research of Cary, LLC
Cary, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
IVA Research
Cincinnati, Ohio, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
BTC of Lincoln Research,LLC
Lincoln, Rhode Island, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
Central Texas Clinical Research, LLC
Austin, Texas, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Ericksen Research & Development, LLC
Clinton, Utah, United States
J. Lewis Research, Inc. Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research Inc.- Foothill Family Clinic South
Salt Lake City, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States
Charlottesville Medical Research, LLC
Charlottesville, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
Clinical Investigation Specialists Inc
Kenosha, Wisconsin, United States
Countries
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References
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Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
Charleston L 4th, Savage-Edwards B, Bragg SM, Baygani SK, Dennehy EB. Migraine history and response to lasmiditan across racial and ethnic groups. Curr Med Res Opin. 2022 May;38(5):721-730. doi: 10.1080/03007995.2022.2057152. Epub 2022 Apr 3.
Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
Lipton RB, Baygani SK, Tepper SJ, Krege JH, Vasudeva R, Pearlman EM, Hauck PM, Loo LS. A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN. J Headache Pain. 2021 Aug 28;22(1):101. doi: 10.1186/s10194-021-01303-w.
Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R. Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies. Clin Ther. 2021 Jun;43(6):1066-1078. doi: 10.1016/j.clinthera.2021.04.004. Epub 2021 Aug 6.
Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI. Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain. Curr Med Res Opin. 2021 Jun;37(6):1031-1038. doi: 10.1080/03007995.2021.1903846. Epub 2021 Apr 7.
Clemow DB, Hochstetler HM, Dong Y, Hauck P, Peres MFP, Ailani J. Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine. Postgrad Med. 2021 May;133(4):449-459. doi: 10.1080/00325481.2020.1860619. Epub 2021 Mar 17.
Clemow DB, Baygani SK, Hauck PM, Hultman CB. Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials. Curr Med Res Opin. 2020 Nov;36(11):1791-1806. doi: 10.1080/03007995.2020.1808780. Epub 2020 Oct 6.
Smith T, Krege JH, Rathmann SS, Dowsett SA, Hake A, Nery ESM, Matthews BR, Doty EG. Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies. Neurol Ther. 2020 Dec;9(2):459-471. doi: 10.1007/s40120-020-00185-5. Epub 2020 May 23.
Knievel K, Buchanan AS, Lombard L, Baygani S, Raskin J, Krege JH, Loo LS, Komori M, Tobin J. Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans. Cephalalgia. 2020 Jan;40(1):19-27. doi: 10.1177/0333102419889350. Epub 2019 Nov 19.
Ashina M, Vasudeva R, Jin L, Lombard L, Gray E, Doty EG, Yunes-Medina L, Kinchen KS, Tassorelli C. Onset of Efficacy Following Oral Treatment With Lasmiditan for the Acute Treatment of Migraine: Integrated Results From 2 Randomized Double-Blind Placebo-Controlled Phase 3 Clinical Studies. Headache. 2019 Nov;59(10):1788-1801. doi: 10.1111/head.13636. Epub 2019 Sep 17.
Shapiro RE, Hochstetler HM, Dennehy EB, Khanna R, Doty EG, Berg PH, Starling AJ. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019 Aug 29;20(1):90. doi: 10.1186/s10194-019-1044-6.
Loo LS, Plato BM, Turner IM, Case MG, Raskin J, Dowsett SA, Krege JH. Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). BMC Neurol. 2019 Aug 13;19(1):191. doi: 10.1186/s12883-019-1420-5.
Loo LS, Ailani J, Schim J, Baygani S, Hundemer HP, Port M, Krege JH. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019 Jul 24;20(1):84. doi: 10.1186/s10194-019-1032-x.
Doty EG, Krege JH, Jin L, Raskin J, Halker Singh RB, Kalidas K. Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine. Cephalalgia. 2019 Oct;39(12):1569-1576. doi: 10.1177/0333102419859313. Epub 2019 Jul 3.
Krege JH, Rizzoli PB, Liffick E, Doty EG, Dowsett SA, Wang J, Buchanan AS. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN. Cephalalgia. 2019 Jul;39(8):957-966. doi: 10.1177/0333102419855080. Epub 2019 Jun 5.
Tepper SJ, Krege JH, Lombard L, Asafu-Adjei JK, Dowsett SA, Raskin J, Buchanan AS, Friedman DI. Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials. Headache. 2019 Jul;59(7):1052-1062. doi: 10.1111/head.13544. Epub 2019 Jun 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H8H-CD-LAHK
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005689-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COL MIG-302
Identifier Type: OTHER
Identifier Source: secondary_id
16889
Identifier Type: -
Identifier Source: org_study_id
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