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

September 5, 2019 updated by: Eli Lilly and Company

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)

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 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.

Study Type

Interventional

Enrollment (Actual)

3005

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, 35235
        • Alabama Clinical Therapeutics, LLC
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc. - ARC
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • 21st Century Neurology
    • California
      • Anaheim, California, United States
        • Anaheim Clinical Trials
      • Carlsbad, California, United States, 92011
        • The Research Center of Southern California
      • Chula Vista, California, United States, 91911
        • eStudySite
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute, Newport Beach
      • Oakland, California, United States, 94612
        • Pacific Research Partners
      • Rancho Mirage, California, United States, 92270
        • Desert Valley Research
      • Redding, California, United States, 96001
        • Northern California Clinical Research Center
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • San Diego, California, United States, 92103
        • California Research Foundation
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80209
        • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Reseach, LLC
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Doral, Florida, United States, 33172
        • The Core Research
      • Fort Myers, Florida, United States, 33901
        • Clinical Research West Coast
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Hollywood, Florida, United States, 33021
        • Infinity Clinical Research, LLC
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Maitland, Florida, United States, 32751
        • Florida Clinical Research
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic, Inc.
      • Miami, Florida, United States, 33133
        • Prestige Clinical Research Center, Inc.
      • Miami, Florida, United States, 33142
        • Floriday Medical Center and Research, Inc.
      • Miami Lakes, Florida, United States, 33104
        • Veritas Research Corporation
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Royal Palm Beach, Florida, United States, 33411
        • Clinical Research Center, LLC
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research, Inc.
      • Tampa, Florida, United States, 33634
        • Meridian Clinical Research, LLC
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30329
        • Pinnacle Trials, Inc.
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Rome, Georgia, United States, 30165
        • Harbin Clinic, LLC
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research, LLC
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research, LLC
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Heartland Research Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, Inc.
      • Lexington, Kentucky, United States, 40513
        • Associates in Neurology, P.S.C.
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC.
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • New Orleans Center for Clinical Research, Inc.
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68114
        • Adirondack Medical Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • Toms River, New Jersey, United States
        • Bio Behavioral Health
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Endwell, New York, United States, 13760
        • Regional Clinical Research, Inc.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville Neurology Specialists, PA
      • Cary, North Carolina, United States, 27518
        • PMG Research of Cary, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Cincinnati, Ohio, United States, 45245
        • IVA Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Partners in Clinical Research
      • Lincoln, Rhode Island, United States, 02865
        • BTC of Lincoln Research,LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research, Inc.
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center, Inc
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37412
        • ClinSearch, LLC
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group, P.C.
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
      • Nashville, Tennessee, United States, 37203
        • Nashville Neuroscience Group
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc.
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research, LLC
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development, LLC
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc.- Foothill Family Clinic South
      • Salt Lake City, Utah, United States, 84157
        • Wasatch Clinical Research
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc. - Jordan River Family Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research, LLC
      • Richmond, Virginia, United States, 23220
        • Clinical Research Partners, LLC
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System Institute for Research and Innovation
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Clinical Investigation Specialists Inc

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

14 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 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.

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: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lasmiditan 50 milligram (mg)
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.
Drug: Lasmiditan 50 mg
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Names:
  • LY573144
Experimental: Lasmiditan 100 mg
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.
Drug: Lasmiditan 100 mg
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Names:
  • LY573144
Experimental: Lasmiditan 200 mg
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.
Drug: Lasmiditan 200 mg
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Names:
  • LY573144
Placebo Comparator: Placebo
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.
Drug: Placebo
Two placebo tablets to match lasmiditan doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Time Frame: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
2 hours post dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Headache Relief
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
Number of Participants With Headache Recurrence
Time Frame: From 2 Hours Post Dose Up to 48 Hours
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)
From 2 Hours Post Dose Up to 48 Hours
Percentage of Participants Use of Rescue Medication
Time Frame: 2 hours post dose
The percentage of participants who used rescue medication.
2 hours post dose
Percentage of Participants Use of Rescue Medication
Time Frame: From 2 Hours Post Dose Up to 24 Hours
The percentage of participants who used rescue medication.
From 2 Hours Post Dose Up to 24 Hours
Percentage of Participants Use of Rescue Medication
Time Frame: From 24 Post Dose Up to 48 Hours
The percentage of participants who used rescue medication.
From 24 Post Dose Up to 48 Hours
Percentage of Participants Nausea Free
Time Frame: 2 hours post dose
The percentage of participant without nausea.
2 hours post dose
Percentage of Participants With Phonophobia Free
Time Frame: 2 hours post dose
The percentage of participants without phonophobia.
2 hours post dose
Percentage of Participants With Photophobia Free
Time Frame: 2 hours post dose
The percentage of participants without photophobia.
2 hours post dose
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
Number of Participants With Treatment Emergent Events
Time Frame: From Baseline Up to End of Study (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
From Baseline Up to End of Study (Up to 11 Weeks)

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

May 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16889
  • H8H-CD-LAHK (Other Identifier: Eli Lilly and Company)
  • 2015-005689-40 (EudraCT Number)
  • COL MIG-302 (Other Identifier: Colucid)

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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