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Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN)

Primary Purpose

Migraine With or Without Aura

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lasmiditan 50 mg
Lasmiditan 100 mg
Lasmiditan 200 mg
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With or Without Aura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • Medical Affiliated Research Center, Inc. - ARC
  • 21st Century Neurology
  • Anaheim Clinical Trials
  • The Research Center of Southern California
  • eStudySite
  • Pharmacology Research Institute
  • Pharmacology Research Institute, Newport Beach
  • Pacific Research Partners
  • Desert Valley Research
  • Northern California Clinical Research Center
  • Anderson Clinical Research
  • California Research Foundation
  • Neurological Research Institute
  • Schuster Medical Research Institute
  • Encompass Clinical Research
  • Diablo Clinical Research, Inc.
  • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
  • Comprehensive Psychiatric Care
  • Chase Medical Research, LLC
  • Nova Clinical Reseach, LLC
  • PAB Clinical Research
  • Meridien Research
  • Avail Clinical Research, LLC
  • The Core Research
  • Clinical Research West Coast
  • Indago Research & Health Center, Inc.
  • Infinity Clinical Research, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Florida Clinical Research
  • Veritas Research Corporation
  • Pharmax Research Clinic, Inc.
  • Prestige Clinical Research Center, Inc.
  • Floriday Medical Center and Research, Inc.
  • Harmony Clinical Research Inc.
  • Compass Research, LLC
  • Clinical Research Center, LLC
  • Meridien Research, Inc.
  • Meridian Clinical Research, LLC
  • Palm Beach Research Center
  • Pinnacle Trials, Inc.
  • Atlanta Center for Medical Research
  • Columbus Regional Research Institute
  • Harbin Clinic, LLC
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research
  • Clinical Investigation Specialists, Inc.
  • Goldpoint Clinical Research, LLC
  • Heartland Research Associates, LLC
  • Central Kentucky Research Associates, Inc.
  • Associates in Neurology, P.S.C.
  • Research Integrity, LLC.
  • New Orleans Center for Clinical Research, Inc.
  • Beacon Clinical Research, LLC
  • Michigan Head Pain & Neurological Institute
  • Clinical Research Institute
  • Adirondack Medical Research Center
  • Meridian Clinical Research, LLC
  • Las Vegas Medical Research
  • Hassman Research Institute
  • Bio Behavioral Health
  • Albuquerque Clinical Trials, Inc.
  • Regional Clinical Research, Inc.
  • Rochester Clinical Research Inc.
  • Asheville Neurology Specialists, PA
  • PMG Research of Cary, LLC
  • Community Research
  • IVA Research
  • Summit Research Network (Oregon) Inc.
  • Partners in Clinical Research
  • BTC of Lincoln Research,LLC
  • Clinical Trials of South Carolina
  • Mountain View Clinical Research, Inc.
  • Coastal Carolina Research Center, Inc
  • Spartanburg Medical Research
  • ClinSearch, LLC
  • Holston Medical Group, P.C.
  • Clinical Neuroscience Solutions, Inc.
  • Nashville Neuroscience Group
  • Central Texas Clinical Research, LLC
  • FutureSearch Trials of Neurology
  • Tekton Research, Inc.
  • FutureSearch Trials of Dallas, LP
  • Protenium Clinical Research
  • Clinical Trials of Texas, Inc.
  • Ericksen Research & Development, LLC
  • J. Lewis Research, Inc. Foothill Family Clinic
  • J. Lewis Research Inc.- Foothill Family Clinic South
  • Jean Brown Research
  • Wasatch Clinical Research
  • J. Lewis Research, Inc. - Jordan River Family Medicine
  • Charlottesville Medical Research, LLC
  • Clinical Research Partners, LLC
  • MultiCare Health System Institute for Research and Innovation
  • Clinical Investigation Specialists Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lasmiditan 50 milligram (mg)

Lasmiditan 100 mg

Lasmiditan 200 mg

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Headache Pain Free at 2 Hours Post Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2015
Last Updated
September 5, 2019
Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02605174
Brief Title
Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
Acronym
SPARTAN
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With or Without Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasmiditan 50 milligram (mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lasmiditan 100 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Lasmiditan 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan 50 mg
Other Intervention Name(s)
LY573144
Intervention Description
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
Intervention Type
Drug
Intervention Name(s)
Lasmiditan 100 mg
Other Intervention Name(s)
LY573144
Intervention Description
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
Intervention Type
Drug
Intervention Name(s)
Lasmiditan 200 mg
Other Intervention Name(s)
LY573144
Intervention Description
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets to match lasmiditan doses.
Primary Outcome Measure Information:
Title
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Description
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time Frame
2 hours post dose
Title
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
Description
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Time Frame
2 hours post dose
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Headache Relief
Description
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Time Frame
2 hours post dose
Title
Number of Participants With Headache Recurrence
Description
The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)
Time Frame
From 2 Hours Post Dose Up to 48 Hours
Title
Percentage of Participants Use of Rescue Medication
Description
The percentage of participants who used rescue medication.
Time Frame
2 hours post dose
Title
Percentage of Participants Use of Rescue Medication
Description
The percentage of participants who used rescue medication.
Time Frame
From 2 Hours Post Dose Up to 24 Hours
Title
Percentage of Participants Use of Rescue Medication
Description
The percentage of participants who used rescue medication.
Time Frame
From 24 Post Dose Up to 48 Hours
Title
Percentage of Participants Nausea Free
Description
The percentage of participant without nausea.
Time Frame
2 hours post dose
Title
Percentage of Participants With Phonophobia Free
Description
The percentage of participants without phonophobia.
Time Frame
2 hours post dose
Title
Percentage of Participants With Photophobia Free
Description
The percentage of participants without photophobia.
Time Frame
2 hours post dose
Title
Percentage of Participants With Resource Utilization
Description
Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study
Time Frame
6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine Attack
Title
Number of Participants With Treatment Emergent Events
Description
Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
Time Frame
From Baseline Up to End of Study (Up to 11 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Medical Affiliated Research Center, Inc. - ARC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
Country
United States
Facility Name
The Research Center of Southern California
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute, Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Desert Valley Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Northern California Clinical Research Center
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Nova Clinical Reseach, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
The Core Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Clinical Research West Coast
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Florida Clinical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Veritas Research Corporation
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33104
Country
United States
Facility Name
Pharmax Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Prestige Clinical Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Floriday Medical Center and Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Harmony Clinical Research Inc.
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Clinical Research Center, LLC
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
Meridien Research, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Pinnacle Trials, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Harbin Clinic, LLC
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Goldpoint Clinical Research, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Associates in Neurology, P.S.C.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Research Integrity, LLC.
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
New Orleans Center for Clinical Research, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Adirondack Medical Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Rochester Clinical Research Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
PMG Research of Cary, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
IVA Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Partners in Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
BTC of Lincoln Research,LLC
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Coastal Carolina Research Center, Inc
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37412
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Central Texas Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Protenium Clinical Research
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ericksen Research & Development, LLC
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
J. Lewis Research, Inc. Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research Inc.- Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
J. Lewis Research, Inc. - Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Charlottesville Medical Research, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Clinical Investigation Specialists Inc
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
36125279
Citation
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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.
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PubMed Identifier
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Citation
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PubMed Identifier
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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.
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PubMed Identifier
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PubMed Identifier
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Learn more about this trial

Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

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