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

December 2, 2019 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lasmiditan 100 mg
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.
Drug: Lasmiditan 100 mg
Other Names:
  • LY573144
Drug: Placebo (matches lasmiditan doses)
Experimental: Lasmiditan 200 mg
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.
Drug: Placebo (matches lasmiditan doses)
Drug: Lasmiditan 200 mg
Other Names:
  • LY573144
Placebo Comparator: Placebo
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.
Drug: Placebo (matches lasmiditan doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Are Headache Pain Free
Time Frame: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
2 hours post dose
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
Time Frame: 2 hours post dose
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
2 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Have Headache Relief After First Dose
Time Frame: 2 hours post dose
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
2 hours post dose
Percentage of Participants With Headache Recurrence
Time Frame: From 2 hours post dose up to 48 hours
Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
From 2 hours post dose up to 48 hours
Percentage of Participants Who Used Rescue Medication
Time Frame: 2 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
2 hours post dose
Percentage of Participants Who Used Rescue Medication
Time Frame: Anytime between 2-24 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Anytime between 2-24 hours post dose
Percentage of Participants Who Used Rescue Medication
Time Frame: Anytime 24-48 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Anytime 24-48 hours post dose
Percentage of Participants Nausea Free
Time Frame: 2 hours post dose
The percentage of participants without nausea.
2 hours post dose
Percentage of Participants Phonophobia Free
Time Frame: 2 hours post dose
The percentage of participants without phonophobia.
2 hours post dose
Percentage of Participants Photophobia Free
Time Frame: 2 hours post dose
The percentage of participants without photophobia.
2 hours post dose
Participants With Serious Adverse Events (SAE)
Time Frame: Baseline up to 11 weeks
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
Baseline up to 11 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Resource Utilization
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
Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study
6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

CoLucid Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16888
  • H8H-CD-LAHJ (Other Identifier: Eli Lilly and Company)
  • COL MIG-301 (Other Identifier: CoLucid Pharmaceuticals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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