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Lasmiditan Compared to Placebo in the Acute Treatment of Migraine: (SAMURAI)

Primary Purpose

Acute Migraine

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

About this trial

This is an interventional treatment trial for Acute Migraine

Eligibility Criteria

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

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.

Sites / Locations

  • Southview Medical Group, P.C.
  • Simon-Williamson Clinic
  • Achieve Clinical Research, LLC
  • East Valley Family Physicians, PC
  • Radiant Research,Inc
  • Warner Family Practice
  • Clinical Research Advantage/Fountain Hills Family Practice
  • Neurological Physicians of Arizona, Inc
  • Thunderbird Internal Medicine
  • Lenzmeier Family Practice
  • Central Arizona Medical Associates, PC
  • Desert Clinical Research
  • Family Practice Specialists, Ltd
  • Clinical Research Advantage Inc./Central Phoenix Medical Center LLC
  • Thunderbird Internal Medicine
  • Tatum Highlands Medical Associates, PLLC
  • Radiant Research, Inc.
  • Fiel Family and Sports Medicine
  • Arizona Community Physicians
  • Orange Grove Family Practice
  • Cassidy Medical Group
  • Allied Clinical Research
  • Artemis Institute for Clinical Research
  • Radiant Research, Inc.
  • Cassidy Medical Group
  • Mile High Primary Care
  • Alpine Clinical Research Center
  • Clinical Research Advantage Inc/Colorado Springs Family Practice
  • Comprehensive Clinical Development- Washington DC
  • Meridien Research
  • MD Clinical
  • Suncoast Research Group
  • CNS Healthcare
  • Radiant Research, Inc.
  • Infinity Clinical Research, LLC
  • Meridien Research
  • Radiant Research Inc
  • Urban Family Practice
  • Georgia Neurology and Sleep Medicine Associates
  • Northwest Clinical Trials
  • Advanced Clinical Research
  • Michigan Avenue Internists
  • Medical and Procedural Specialists of Illinois
  • Radiant Research, Inc
  • Evanston Premier Research LLC
  • Clinical Research Advantage
  • Family Medical Associates
  • Ridge Family Practice
  • Radiant Research Inc./Continuum Health Care
  • Heartland Research
  • Heartland Research
  • Boston Clinical Trials
  • Radiant Research, Inc
  • West Florissant Internists
  • The Center for Pharmaceutical Research
  • Radiant Research, Inc
  • Skyline Medical Center
  • Prairie Fields Family Medicine PC
  • Southwest Family Physicians, PC
  • James Mell, DO
  • Clinical Research Advantage
  • Nevada Family Care
  • Diagnostic Center of Medicine
  • Diagnostic Center of Medicine
  • Clifford Molin/Clinical Research Advantage,Inc
  • Comprehensive Clinical Development - Queens NY
  • Radiant Research,Inc
  • Radiant Research, Inc.
  • Rapid Medical Research, Inc.
  • Radiant Research, Inc
  • Oklahoma City Clinic - Edmund
  • Oklahoma City Clinic - Midwest CIty
  • LION Research
  • Oklahoma City Clinic- Central/Clinical Research Advantage INC
  • Lynn Health Science Institute
  • Sunstone Medical Research,LLC
  • Oregon Center for Clinical Investigations, Inc.
  • Thomas Jefferson University
  • West Bay Clinical Research
  • Primary Care Associates, PA
  • Radiant Research, Inc
  • Medical Research South
  • Radiant Research, Inc
  • Volunteer Research Group
  • Family Medical Associates of Texas
  • Premier Family Physicians
  • Radiant Research, Inc
  • Village Health Center
  • Doctors of Internal Medicine
  • Plano Internal Medicine
  • Radiant Research
  • Radiant Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lasmiditan 100 mg

Lasmiditan 200 mg

Placebo

Arm Description

Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.

Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.

Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Are Headache Pain Free
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

Percentage of Participants Who Have Headache Relief After First Dose
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Percentage of Participants With Headache Recurrence
Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Percentage of Participants Nausea Free
The percentage of participants without nausea.
Percentage of Participants Phonophobia Free
The percentage of participants without phonophobia.
Percentage of Participants Photophobia Free
The percentage of participants without photophobia.
Participants With Serious Adverse Events (SAE)
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

Full Information

First Posted
March 18, 2015
Last Updated
December 2, 2019
Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02439320
Brief Title
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
Acronym
SAMURAI
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasmiditan 100 mg
Arm Type
Experimental
Arm Description
Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Arm Title
Lasmiditan 200 mg
Arm Type
Experimental
Arm Description
Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan 100 mg
Other Intervention Name(s)
LY573144
Intervention Type
Drug
Intervention Name(s)
Lasmiditan 200 mg
Other Intervention Name(s)
LY573144
Intervention Type
Drug
Intervention Name(s)
Placebo (matches lasmiditan doses)
Primary Outcome Measure Information:
Title
Percentage of Participants Who Are Headache Pain Free
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Have Headache Relief After First Dose
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
Percentage of Participants With Headache Recurrence
Description
Participants who received study drug and 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 Who Used Rescue Medication
Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time Frame
2 hours post dose
Title
Percentage of Participants Who Used Rescue Medication
Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time Frame
Anytime between 2-24 hours post dose
Title
Percentage of Participants Who Used Rescue Medication
Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time Frame
Anytime 24-48 hours post dose
Title
Percentage of Participants Nausea Free
Description
The percentage of participants without nausea.
Time Frame
2 hours post dose
Title
Percentage of Participants Phonophobia Free
Description
The percentage of participants without phonophobia.
Time Frame
2 hours post dose
Title
Percentage of Participants Photophobia Free
Description
The percentage of participants without photophobia.
Time Frame
2 hours post dose
Title
Participants With Serious Adverse Events (SAE)
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
Baseline up to 11 weeks
Other Pre-specified Outcome Measures:
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

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. 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.
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
Southview Medical Group, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Simon-Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35261
Country
United States
Facility Name
East Valley Family Physicians, PC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Radiant Research,Inc
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Warner Family Practice
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Research Advantage/Fountain Hills Family Practice
City
Fountain Hills
State/Province
Arizona
ZIP/Postal Code
85268
Country
United States
Facility Name
Neurological Physicians of Arizona, Inc
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Thunderbird Internal Medicine
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Lenzmeier Family Practice
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Central Arizona Medical Associates, PC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Desert Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Family Practice Specialists, Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Advantage Inc./Central Phoenix Medical Center LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Thunderbird Internal Medicine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Tatum Highlands Medical Associates, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Radiant Research, Inc.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Fiel Family and Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Arizona Community Physicians
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Cassidy Medical Group
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Allied Clinical Research
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Radiant Research, Inc.
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Cassidy Medical Group
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Mile High Primary Care
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Clinical Research Advantage Inc/Colorado Springs Family Practice
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Comprehensive Clinical Development- Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Radiant Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Urban Family Practice
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Georgia Neurology and Sleep Medicine Associates
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Michigan Avenue Internists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60604
Country
United States
Facility Name
Medical and Procedural Specialists of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
Radiant Research, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Evanston Premier Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Research Advantage
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Family Medical Associates
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47725
Country
United States
Facility Name
Ridge Family Practice
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Radiant Research Inc./Continuum Health Care
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Heartland Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Radiant Research, Inc
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
West Florissant Internists
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Radiant Research, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Skyline Medical Center
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Prairie Fields Family Medicine PC
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Southwest Family Physicians, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
James Mell, DO
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Clinical Research Advantage
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Nevada Family Care
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Diagnostic Center of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Diagnostic Center of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Facility Name
Clifford Molin/Clinical Research Advantage,Inc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Clinical Development - Queens NY
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Radiant Research,Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Radiant Research, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oklahoma City Clinic - Edmund
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Oklahoma City Clinic - Midwest CIty
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Facility Name
LION Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Oklahoma City Clinic- Central/Clinical Research Advantage INC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sunstone Medical Research,LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
West Bay Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Primary Care Associates, PA
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research, Inc
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical Research South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Radiant Research, Inc
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Family Medical Associates of Texas
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Premier Family Physicians
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
Radiant Research, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Village Health Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Doctors of Internal Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Plano Internal Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
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
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.
Results Reference
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PubMed Identifier
35779194
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.
Results Reference
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PubMed Identifier
35471625
Citation
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.
Results Reference
derived
PubMed Identifier
35350937
Citation
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.
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derived
PubMed Identifier
34644189
Citation
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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Citation
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.
Results Reference
derived
PubMed Identifier
34366152
Citation
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.
Results Reference
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PubMed Identifier
33784930
Citation
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.
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PubMed Identifier
33730977
Citation
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.
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PubMed Identifier
32783644
Citation
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.
Results Reference
derived
PubMed Identifier
32447545
Citation
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.
Results Reference
derived
PubMed Identifier
31744319
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.
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PubMed Identifier
31529622
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.
Results Reference
derived
PubMed Identifier
31464581
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.
Results Reference
derived
PubMed Identifier
31409292
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.
Results Reference
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PubMed Identifier
31340760
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.
Results Reference
derived
PubMed Identifier
31266353
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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PubMed Identifier
31166697
Citation
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. Erratum In: Cephalalgia. 2021 Aug;41(9):1035.
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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. Erratum In: Headache. 2019 Nov;59(10):1875.
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Learn more about this trial

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

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