Clinical trial NCT02439320: Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: CoLucid Pharmaceuticals
First posted: 2015-05-08
Enrollment: 2231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

Eligibility criteria: Inclusion Criteria:

* Able and willing to give written informed consent.
* 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.
* 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 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 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.

Primary outcomes:
measure: Percentage of Participants Who Are Headache Pain Free
timeFrame: 2 hours post dose
measure: Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Percentage of Participants Who Have Headache Relief After First Dose
timeFrame: 2 hours post dose
measure: Percentage of Participants With Headache Recurrence
timeFrame: From 2 hours post dose up to 48 hours
measure: Percentage of Participants Who Used Rescue Medication
timeFrame: 2 hours post dose
measure: Percentage of Participants Who Used Rescue Medication
timeFrame: Anytime between 2-24 hours post dose
measure: Percentage of Participants Who Used Rescue Medication
timeFrame: Anytime 24-48 hours post dose
measure: Percentage of Participants Nausea Free
timeFrame: 2 hours post dose
measure: Percentage of Participants Phonophobia Free
timeFrame: 2 hours post dose
measure: Percentage of Participants Photophobia Free
timeFrame: 2 hours post dose
measure: Participants With Serious Adverse Events (SAE)
timeFrame: Baseline up to 11 weeks
Other outcomes:
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
Locations:
city: Birmingham
country: United States
facility: Southview Medical Group, P.C.
state: Alabama
city: Birmingham
country: United States
facility: Simon-Williamson Clinic
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians, PC
state: Arizona
city: Chandler
country: United States
facility: Radiant Research,Inc
state: Arizona
city: Chandler
country: United States
facility: Warner Family Practice
state: Arizona
city: Fountain Hills
country: United States
facility: Clinical Research Advantage/Fountain Hills Family Practice
state: Arizona
city: Gilbert
country: United States
facility: Neurological Physicians of Arizona, Inc
state: Arizona
city: Glendale
country: United States
facility: Thunderbird Internal Medicine
state: Arizona
city: Glendale
country: United States
facility: Lenzmeier Family Practice
state: Arizona
city: Mesa
country: United States
facility: Central Arizona Medical Associates, PC
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists, Ltd
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage Inc./Central Phoenix Medical Center LLC
state: Arizona
city: Phoenix
country: United States
facility: Thunderbird Internal Medicine
state: Arizona
city: Phoenix
country: United States
facility: Tatum Highlands Medical Associates, PLLC
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Tucson
country: United States
facility: Arizona Community Physicians
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Carlsbad
country: United States
facility: Cassidy Medical Group
state: California
city: Gold River
country: United States
facility: Allied Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Vista
country: United States
facility: Cassidy Medical Group
state: California
city: Aurora
country: United States
facility: Mile High Primary Care
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage Inc/Colorado Springs Family Practice
state: Colorado
city: Washington
country: United States
facility: Comprehensive Clinical Development- Washington DC
state: District of Columbia
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Radiant Research Inc
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Associates
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Michigan Avenue Internists
state: Illinois
city: Chicago
country: United States
facility: Medical and Procedural Specialists of Illinois
state: Illinois
city: Chicago
country: United States
facility: Radiant Research, Inc
state: Illinois
city: Evanston
country: United States
facility: Evanston Premier Research LLC
state: Illinois
city: Evansville
country: United States
facility: Clinical Research Advantage
state: Indiana
city: Evansville
country: United States
facility: Family Medical Associates
state: Indiana
city: Council Bluffs
country: United States
facility: Ridge Family Practice
state: Iowa
city: Overland Park
country: United States
facility: Radiant Research Inc./Continuum Health Care
state: Kansas
city: Wichita
country: United States
facility: Heartland Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research, Inc
state: Minnesota
city: Bridgeton
country: United States
facility: West Florissant Internists
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research, Inc
state: Missouri
city: Elkhorn
country: United States
facility: Skyline Medical Center
state: Nebraska
city: Fremont
country: United States
facility: Prairie Fields Family Medicine PC
state: Nebraska
city: Omaha
country: United States
facility: Southwest Family Physicians, PC
state: Nebraska
city: Henderson
country: United States
facility: James Mell, DO
state: Nevada
city: Henderson
country: United States
facility: Clinical Research Advantage
state: Nevada
city: Henderson
country: United States
facility: Nevada Family Care
state: Nevada
city: Las Vegas
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Clifford Molin/Clinical Research Advantage,Inc
state: Nevada
city: Jamaica
country: United States
facility: Comprehensive Clinical Development - Queens NY
state: New York
city: Akron
country: United States
facility: Radiant Research,Inc
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Edmond
country: United States
facility: Oklahoma City Clinic - Edmund
state: Oklahoma
city: Midwest City
country: United States
facility: Oklahoma City Clinic - Midwest CIty
state: Oklahoma
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma City Clinic- Central/Clinical Research Advantage INC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research,LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Primary Care Associates, PA
state: South Carolina
city: Anderson
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Allen
country: United States
facility: Family Medical Associates of Texas
state: Texas
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Dallas
country: United States
facility: Radiant Research, Inc
state: Texas
city: Plano
country: United States
facility: Village Health Center
state: Texas
city: Plano
country: United States
facility: Doctors of Internal Medicine
state: Texas
city: Plano
country: United States
facility: Plano Internal Medicine
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Murray
country: United States
facility: Radiant Research
state: Utah
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: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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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.
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