Clinical trial NCT02605174: Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
Official title: A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With or Without Aura
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: CoLucid Pharmaceuticals
First posted: 2015-11-16
Enrollment: 3005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants 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 participant's study participation will consist of screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Eligibility criteria: Inclusion Criteria:

* Able and willing to give written informed consent and authorize HIPAA.
* 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:

* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
* 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.

Primary outcomes:
measure: Percentage of Participants Headache Pain Free at 2 Hours Post Dose
timeFrame: 2 hours post dose
measure: Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
timeFrame: 2 hours post dose
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Headache Relief
timeFrame: 2 hours post dose
measure: Number of Participants With Headache Recurrence
timeFrame: From 2 Hours Post Dose Up to 48 Hours
measure: Percentage of Participants Use of Rescue Medication
timeFrame: 2 hours post dose
measure: Percentage of Participants Use of Rescue Medication
timeFrame: From 2 Hours Post Dose Up to 24 Hours
measure: Percentage of Participants Use of Rescue Medication
timeFrame: From 24 Post Dose Up to 48 Hours
measure: Percentage of Participants Nausea Free
timeFrame: 2 hours post dose
measure: Percentage of Participants With Phonophobia Free
timeFrame: 2 hours post dose
measure: Percentage of Participants With Photophobia Free
timeFrame: 2 hours post dose
measure: Percentage of Participants With Resource Utilization
timeFrame: 6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine Attack
measure: Number of Participants With Treatment Emergent Events
timeFrame: From Baseline Up to End of Study (Up to 11 Weeks)
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc. - ARC
state: Alabama
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Carlsbad
country: United States
facility: The Research Center of Southern California
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute, Newport Beach
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Research
state: California
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Denver
country: United States
facility: Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Nova Clinical Reseach, LLC
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Doral
country: United States
facility: The Core Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Research West Coast
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Veritas Research Corporation
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Floriday Medical Center and Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Royal Palm Beach
country: United States
facility: Clinical Research Center, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridian Clinical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Lexington
country: United States
facility: Associates in Neurology, P.S.C.
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC.
state: Kentucky
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research, Inc.
state: Louisiana
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Omaha
country: United States
facility: Adirondack Medical Research Center
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research Inc.
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: IVA Research
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Lincoln
country: United States
facility: BTC of Lincoln Research,LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development, LLC
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.- Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. - Jordan River Family Medicine
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System Institute for Research and Innovation
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.
citation: 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.
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citation: 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.
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citation: 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.