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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)

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ClinicalTrials.gov Identifier: NCT02605174
Recruitment Status : Completed
First Posted : November 16, 2015
Results First Posted : July 30, 2018
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Lasmiditan 50 mg Drug: Lasmiditan 100 mg Drug: Lasmiditan 200 mg Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3005 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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. 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.


Other Outcome Measures:
  1. 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. 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)

  3. Percentage of Participants Use of Rescue Medication [ Time Frame: 2 hours post dose ]
    The percentage of participants who used rescue medication.

  4. 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.

  5. 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.

  6. Percentage of Participants Nausea Free [ Time Frame: 2 hours post dose ]
    The percentage of participant without nausea.

  7. Percentage of Participants With Phonophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without phonophobia.

  8. Percentage of Participants With Photophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without photophobia.

  9. 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

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605174


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

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] November 30, 2015
Statistical Analysis Plan  [PDF] July 18, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02605174     History of Changes
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 )
First Posted: November 16, 2015    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases