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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02605174
Collaborator
CoLucid Pharmaceuticals (Industry)
3,005
Enrollment
95
Locations
4
Arms
14
Duration (Months)
31.6
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 1, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Headache Pain Free at 2 Hours Post Dose [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 [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 [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 [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 [2 hours post dose]

      The percentage of participants who used rescue medication.

    4. Percentage of Participants Use of Rescue Medication [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 [From 24 Post Dose Up to 48 Hours]

      The percentage of participants who used rescue medication.

    6. Percentage of Participants Nausea Free [2 hours post dose]

      The percentage of participant without nausea.

    7. Percentage of Participants With Phonophobia Free [2 hours post dose]

      The percentage of participants without phonophobia.

    8. Percentage of Participants With Photophobia Free [2 hours post dose]

      The percentage of participants without photophobia.

    9. Percentage of Participants With Resource Utilization [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Clinical Therapeutics, LLC Birmingham Alabama United States 35235
    2 Medical Affiliated Research Center, Inc. - ARC Huntsville Alabama United States 35801
    3 21st Century Neurology Phoenix Arizona United States 85004
    4 Anaheim Clinical Trials Anaheim California United States
    5 The Research Center of Southern California Carlsbad California United States 92011
    6 eStudySite Chula Vista California United States 91911
    7 Pharmacology Research Institute Los Alamitos California United States 90720
    8 Pharmacology Research Institute, Newport Beach Newport Beach California United States 92660
    9 Pacific Research Partners Oakland California United States 94612
    10 Desert Valley Research Rancho Mirage California United States 92270
    11 Northern California Clinical Research Center Redding California United States 96001
    12 Anderson Clinical Research Redlands California United States 92374
    13 California Research Foundation San Diego California United States 92103
    14 Neurological Research Institute Santa Monica California United States 90404
    15 Schuster Medical Research Institute Sherman Oaks California United States 91403
    16 Encompass Clinical Research Spring Valley California United States 91978
    17 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
    18 Lytle and Weiss, PLLC dba Clinical Trials of the Rockies Denver Colorado United States 80209
    19 Comprehensive Psychiatric Care Norwich Connecticut United States 06360
    20 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    21 Nova Clinical Reseach, LLC Bradenton Florida United States 34209
    22 PAB Clinical Research Brandon Florida United States 33511
    23 Meridien Research Brooksville Florida United States 34601
    24 Avail Clinical Research, LLC DeLand Florida United States 32720
    25 The Core Research Doral Florida United States 33172
    26 Clinical Research West Coast Fort Myers Florida United States 33901
    27 Indago Research & Health Center, Inc. Hialeah Florida United States 33012
    28 Infinity Clinical Research, LLC Hollywood Florida United States 33021
    29 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
    30 Florida Clinical Research Maitland Florida United States 32751
    31 Veritas Research Corporation Miami Lakes Florida United States 33104
    32 Pharmax Research Clinic, Inc. Miami Florida United States 33126
    33 Prestige Clinical Research Center, Inc. Miami Florida United States 33133
    34 Floriday Medical Center and Research, Inc. Miami Florida United States 33142
    35 Harmony Clinical Research Inc. North Miami Beach Florida United States 33162
    36 Compass Research, LLC Orlando Florida United States 32806
    37 Clinical Research Center, LLC Royal Palm Beach Florida United States 33411
    38 Meridien Research, Inc. Saint Petersburg Florida United States 33709
    39 Meridian Clinical Research, LLC Tampa Florida United States 33634
    40 Palm Beach Research Center West Palm Beach Florida United States 33409
    41 Pinnacle Trials, Inc. Atlanta Georgia United States 30329
    42 Atlanta Center for Medical Research Atlanta Georgia United States 30331
    43 Columbus Regional Research Institute Columbus Georgia United States 31904
    44 Harbin Clinic, LLC Rome Georgia United States 30165
    45 Meridian Clinical Research, LLC Savannah Georgia United States 31406
    46 Meridian Clinical Research Savannah Georgia United States 31406
    47 Clinical Investigation Specialists, Inc. Gurnee Illinois United States 60031
    48 Goldpoint Clinical Research, LLC Indianapolis Indiana United States 46260
    49 Heartland Research Associates, LLC Augusta Kansas United States 67010
    50 Central Kentucky Research Associates, Inc. Lexington Kentucky United States 40509
    51 Associates in Neurology, P.S.C. Lexington Kentucky United States 40513
    52 Research Integrity, LLC. Owensboro Kentucky United States 42303
    53 New Orleans Center for Clinical Research, Inc. New Orleans Louisiana United States 70119
    54 Beacon Clinical Research, LLC Quincy Massachusetts United States 02169
    55 Michigan Head Pain & Neurological Institute Ann Arbor Michigan United States 48104
    56 Clinical Research Institute Plymouth Minnesota United States 55441
    57 Adirondack Medical Research Center Omaha Nebraska United States 68114
    58 Meridian Clinical Research, LLC Omaha Nebraska United States 68134
    59 Las Vegas Medical Research Las Vegas Nevada United States 89128
    60 Hassman Research Institute Berlin New Jersey United States 08009
    61 Bio Behavioral Health Toms River New Jersey United States
    62 Albuquerque Clinical Trials, Inc. Albuquerque New Mexico United States 87102
    63 Regional Clinical Research, Inc. Endwell New York United States 13760
    64 Rochester Clinical Research Inc. Rochester New York United States 14609
    65 Asheville Neurology Specialists, PA Asheville North Carolina United States 28806
    66 PMG Research of Cary, LLC Cary North Carolina United States 27518
    67 Community Research Cincinnati Ohio United States 45227
    68 IVA Research Cincinnati Ohio United States 45245
    69 Summit Research Network (Oregon) Inc. Portland Oregon United States 97210
    70 Partners in Clinical Research Cumberland Rhode Island United States 02864
    71 BTC of Lincoln Research,LLC Lincoln Rhode Island United States 02865
    72 Clinical Trials of South Carolina Charleston South Carolina United States 29406
    73 Mountain View Clinical Research, Inc. Greer South Carolina United States 29651
    74 Coastal Carolina Research Center, Inc Mount Pleasant South Carolina United States 29464
    75 Spartanburg Medical Research Spartanburg South Carolina United States 29303
    76 ClinSearch, LLC Chattanooga Tennessee United States 37412
    77 Holston Medical Group, P.C. Kingsport Tennessee United States 37660
    78 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
    79 Nashville Neuroscience Group Nashville Tennessee United States 37203
    80 Central Texas Clinical Research, LLC Austin Texas United States 78705
    81 FutureSearch Trials of Neurology Austin Texas United States 78731
    82 Tekton Research, Inc. Austin Texas United States 78745
    83 FutureSearch Trials of Dallas, LP Dallas Texas United States 75231
    84 Protenium Clinical Research Hurst Texas United States 76054
    85 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
    86 Ericksen Research & Development, LLC Clinton Utah United States 84015
    87 J. Lewis Research, Inc. Foothill Family Clinic Salt Lake City Utah United States 84109
    88 J. Lewis Research Inc.- Foothill Family Clinic South Salt Lake City Utah United States 84121
    89 Jean Brown Research Salt Lake City Utah United States 84124
    90 Wasatch Clinical Research Salt Lake City Utah United States 84157
    91 J. Lewis Research, Inc. - Jordan River Family Medicine South Jordan Utah United States 84095
    92 Charlottesville Medical Research, LLC Charlottesville Virginia United States 22911
    93 Clinical Research Partners, LLC Richmond Virginia United States 23220
    94 MultiCare Health System Institute for Research and Innovation Tacoma Washington United States 98405
    95 Clinical Investigation Specialists Inc Kenosha Wisconsin United States 53142

    Sponsors and Collaborators

    • Eli Lilly and Company
    • CoLucid Pharmaceuticals

    Investigators

    • 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)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02605174
    Other Study ID Numbers:
    • 16889
    • H8H-CD-LAHK
    • 2015-005689-40
    • COL MIG-302
    First Posted:
    Nov 16, 2015
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Migraine Disorders
    Lasmiditan

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants were randomly assigned to 1 of 7 sequences and received lasmiditan 50 mg (L50 mg), lasmiditan 100 mg (L100 mg) or lasmiditan 200 mg (L200 mg) or placebo (P) for the first dose and the second dose, if needed for rescue or recurrence of migraine.
    Arm/Group Title Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmitidan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmitidan 200 mg/Placebo Placebo/Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Period Title: Overall Study
    STARTED 501 249 502 252 501 249 751
    Received at Least 1 Dose of Study Drug 429 225 423 212 434 215 645
    Received Optional 2nd Dose 206 96 177 83 144 74 361
    COMPLETED 437 226 426 216 448 217 662
    NOT COMPLETED 64 23 76 36 53 32 89

    Baseline Characteristics

    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo Total
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Total of all reporting groups
    Overall Participants 654 635 649 645 2583
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.8
    (13.20)
    43.4
    (12.59)
    41.8
    (12.40)
    42.6
    (12.90)
    42.7
    (12.79)
    Sex: Female, Male (Count of Participants)
    Female
    554
    84.7%
    539
    84.9%
    536
    82.6%
    545
    84.5%
    2174
    84.2%
    Male
    100
    15.3%
    96
    15.1%
    113
    17.4%
    100
    15.5%
    409
    15.8%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    3
    0.5%
    2
    0.3%
    2
    0.3%
    5
    0.8%
    12
    0.5%
    Asian
    5
    0.8%
    6
    0.9%
    7
    1.1%
    3
    0.5%
    21
    0.8%
    Black or African American
    106
    16.2%
    104
    16.4%
    106
    16.3%
    110
    17.1%
    426
    16.5%
    Native Hawaiian or other Pacific Islander
    2
    0.3%
    1
    0.2%
    2
    0.3%
    2
    0.3%
    7
    0.3%
    White
    524
    80.1%
    509
    80.2%
    522
    80.4%
    516
    80%
    2071
    80.2%
    Other
    6
    0.9%
    8
    1.3%
    4
    0.6%
    4
    0.6%
    22
    0.9%
    Multiple
    8
    1.2%
    5
    0.8%
    5
    0.8%
    5
    0.8%
    23
    0.9%
    Missing
    0
    0%
    0
    0%
    1
    0.2%
    0
    0%
    1
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    135
    20.6%
    137
    21.6%
    136
    21%
    124
    19.2%
    532
    20.6%
    Not Hispanic or Latino
    515
    78.7%
    493
    77.6%
    511
    78.7%
    518
    80.3%
    2037
    78.9%
    Not Reported
    3
    0.5%
    3
    0.5%
    0
    0%
    3
    0.5%
    9
    0.3%
    Unknown
    1
    0.2%
    2
    0.3%
    1
    0.2%
    0
    0%
    4
    0.2%
    Missing
    0
    0%
    0
    0%
    1
    0.2%
    0
    0%
    1
    0%
    Region of Enrollment (Count of Participants)
    Germany
    77
    11.8%
    79
    12.4%
    77
    11.9%
    77
    11.9%
    310
    12%
    United Kingdom
    48
    7.3%
    48
    7.6%
    47
    7.2%
    48
    7.4%
    191
    7.4%
    United States
    625
    95.6%
    627
    98.7%
    626
    96.5%
    626
    97.1%
    2504
    96.9%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 556 532 528 539
    Number [percentage of participants]
    28.6
    4.4%
    31.4
    4.9%
    38.8
    6%
    21.3
    3.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    1.1 to 1.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    1.3 to 2.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    1.8 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable MBS data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 512 500 483 514
    Number [percentage of participants]
    40.8
    6.2%
    44.2
    7%
    48.7
    7.5%
    33.5
    5.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    1.1 to 1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    1.2 to 2.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.9
    Confidence Interval (2-Sided) 95%
    1.4 to 2.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Other Pre-specified Outcome
    Title Percentage of Participants With Headache Relief
    Description The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
    Time Frame 2 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable headache relief data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 575
    Number [percentage of participants]
    59.0
    9%
    64.8
    10.2%
    65.0
    10%
    47.7
    7.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    1.3 to 2.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    1.7 to 2.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    1.8 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Other Pre-specified Outcome
    Title Number of Participants With Headache Recurrence
    Description The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)
    Time Frame From 2 Hours Post Dose Up to 48 Hours

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 159 167 205 115
    Count of Participants [Participants]
    38
    5.8%
    44
    6.9%
    52
    8%
    26
    4%
    5. Other Pre-specified Outcome
    Title Percentage of Participants Use of Rescue Medication
    Description The percentage of participants who used rescue medication.
    Time Frame 2 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    31.9
    4.9%
    26.4
    4.2%
    18.9
    2.9%
    40.8
    6.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    0.5 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    0.4 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    0.3 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Other Pre-specified Outcome
    Title Percentage of Participants Use of Rescue Medication
    Description The percentage of participants who used rescue medication.
    Time Frame From 2 Hours Post Dose Up to 24 Hours

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    8.9
    1.4%
    6.3
    1%
    7.4
    1.1%
    8.7
    1.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.917
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.7 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.129
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    0.5 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.456
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    0.6 to 1.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Other Pre-specified Outcome
    Title Percentage of Participants Use of Rescue Medication
    Description The percentage of participants who used rescue medication.
    Time Frame From 24 Post Dose Up to 48 Hours

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    8. Other Pre-specified Outcome
    Title Percentage of Participants Nausea Free
    Description The percentage of participant without nausea.
    Time Frame 2 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable nausea free data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    68.7
    10.5%
    71.8
    11.3%
    70.4
    10.8%
    70.3
    10.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.522
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    0.7 to 1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.622
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    0.8 to 1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.992
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.8 to 1.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Other Pre-specified Outcome
    Title Percentage of Participants With Phonophobia Free
    Description The percentage of participants without phonophobia.
    Time Frame 2 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    61.2
    9.4%
    64.8
    10.2%
    65.3
    10.1%
    53.5
    8.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    1.1 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    1.3 to 2.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    1.3 to 2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Other Pre-specified Outcome
    Title Percentage of Participants With Photophobia Free
    Description The percentage of participants without photophobia.
    Time Frame 2 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 598 571 565 576
    Number [percentage of participants]
    51.2
    7.8%
    56.4
    8.9%
    58.2
    9%
    43.2
    6.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    1.1 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 100 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    1.3 to 2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lasmiditan 200 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    1.4 to 2.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had received at least one dose of study drug and had evaluable resource utilization data.
    Arm/Group Title Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 429 225 423 212 434 215 645
    6 months prior to enrolling
    4.7
    0.7%
    2.2
    0.3%
    2.8
    0.4%
    2.4
    0.4%
    3.2
    0.1%
    3.3
    NaN
    2.9
    NaN
    During time of study
    0.5
    0.1%
    0
    0%
    0.5
    0.1%
    0
    0%
    0.9
    0%
    0.5
    NaN
    0.6
    NaN
    12. Other Pre-specified Outcome
    Title Number of Participants With Treatment Emergent Events
    Description Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
    Time Frame From Baseline Up to End of Study (Up to 11 Weeks)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.
    Arm/Group Title Lasmiditan 50 mg Lasmiditan 100 mg Lasmiditan 200 mg Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
    Measure Participants 654 635 649 645
    Number [participants]
    167
    25.5%
    230
    36.2%
    253
    39%
    75
    11.6%

    Adverse Events

    Time Frame From Baseline Up to End of Study (Up to 11 Weeks)
    Adverse Event Reporting Description The safety population includes all participants who received at least one dose of study drug and the optional second dose.
    Arm/Group Title Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
    Arm/Group Description Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.
    All Cause Mortality
    Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/429 (0%) 0/225 (0%) 0/423 (0%) 0/212 (0%) 0/435 (0%) 0/217 (0%) 0/646 (0%)
    Serious Adverse Events
    Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/429 (0.2%) 0/225 (0%) 1/423 (0.2%) 1/212 (0.5%) 3/435 (0.7%) 0/217 (0%) 2/646 (0.3%)
    Gastrointestinal disorders
    Intestinal obstruction 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Hepatobiliary disorders
    Cholelithiasis 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pituitary tumour benign 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Nervous system disorders
    Presyncope 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Psychiatric disorders
    Somatisation disorder 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Surgical and medical procedures
    Surgery 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Vascular disorders
    Deep vein thrombosis 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Hypotension 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Other (Not Including Serious) Adverse Events
    Lasmiditan 50 mg/Lasmiditan 50 mg Lasmiditan 50 mg/Placebo Lasmiditan 100 mg/Lasmiditan 100 mg Lasmiditan 100 mg/Placebo Lasmiditan 200 mg/Lasmiditan 200 mg Lasmiditan 200 mg/Placebo Placebo/Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 118/429 (27.5%) 61/225 (27.1%) 149/423 (35.2%) 94/212 (44.3%) 177/435 (40.7%) 87/217 (40.1%) 80/646 (12.4%)
    Cardiac disorders
    Palpitations 3/429 (0.7%) 4 0/225 (0%) 0 1/423 (0.2%) 1 1/212 (0.5%) 1 1/435 (0.2%) 1 1/217 (0.5%) 2 1/646 (0.2%) 1
    Tachycardia 0/429 (0%) 0 1/225 (0.4%) 1 2/423 (0.5%) 2 0/212 (0%) 0 1/435 (0.2%) 1 1/217 (0.5%) 1 0/646 (0%) 0
    Ear and labyrinth disorders
    Ear discomfort 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Motion sickness 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Tinnitus 1/429 (0.2%) 1 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 1/646 (0.2%) 1
    Vertigo 1/429 (0.2%) 1 1/225 (0.4%) 1 3/423 (0.7%) 3 2/212 (0.9%) 3 3/435 (0.7%) 3 2/217 (0.9%) 2 1/646 (0.2%) 1
    Endocrine disorders
    Hyperthyroidism 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Eye disorders
    Blepharospasm 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Chromatopsia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Keratitis 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Mydriasis 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Ocular hyperaemia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Photopsia 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Strabismus 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Vision blurred 1/429 (0.2%) 1 0/225 (0%) 0 1/423 (0.2%) 1 2/212 (0.9%) 2 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Visual acuity reduced 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Visual impairment 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 1/212 (0.5%) 1 2/435 (0.5%) 2 1/217 (0.5%) 1 0/646 (0%) 0
    Vitreous floaters 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Abdominal pain 0/429 (0%) 0 1/225 (0.4%) 1 1/423 (0.2%) 1 2/212 (0.9%) 2 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Abdominal pain upper 2/429 (0.5%) 2 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 1/217 (0.5%) 1 0/646 (0%) 0
    Diarrhoea 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 2 0/212 (0%) 0 1/435 (0.2%) 1 1/217 (0.5%) 1 1/646 (0.2%) 2
    Dry mouth 2/429 (0.5%) 3 0/225 (0%) 0 1/423 (0.2%) 1 1/212 (0.5%) 1 2/435 (0.5%) 2 1/217 (0.5%) 1 2/646 (0.3%) 2
    Dyspepsia 1/429 (0.2%) 1 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Hypoaesthesia oral 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Lip dry 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Nausea 12/429 (2.8%) 12 6/225 (2.7%) 6 13/423 (3.1%) 13 9/212 (4.2%) 9 14/435 (3.2%) 14 4/217 (1.8%) 4 9/646 (1.4%) 9
    Paraesthesia oral 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 3/435 (0.7%) 3 0/217 (0%) 0 1/646 (0.2%) 1
    Retching 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Toothache 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Vomiting 1/429 (0.2%) 2 4/225 (1.8%) 4 2/423 (0.5%) 2 2/212 (0.9%) 2 3/435 (0.7%) 3 3/217 (1.4%) 3 3/646 (0.5%) 3
    General disorders
    Asthenia 2/429 (0.5%) 2 2/225 (0.9%) 2 2/423 (0.5%) 2 4/212 (1.9%) 4 8/435 (1.8%) 8 4/217 (1.8%) 4 1/646 (0.2%) 1
    Chest discomfort 0/429 (0%) 0 2/225 (0.9%) 2 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 2/217 (0.9%) 2 2/646 (0.3%) 2
    Chills 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 2/646 (0.3%) 2
    Face oedema 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Fatigue 13/429 (3%) 13 7/225 (3.1%) 7 13/423 (3.1%) 13 15/212 (7.1%) 15 21/435 (4.8%) 21 12/217 (5.5%) 12 6/646 (0.9%) 6
    Feeling abnormal 0/429 (0%) 0 2/225 (0.9%) 2 3/423 (0.7%) 3 1/212 (0.5%) 1 4/435 (0.9%) 4 1/217 (0.5%) 1 1/646 (0.2%) 1
    Feeling cold 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 1/646 (0.2%) 1
    Feeling hot 0/429 (0%) 0 0/225 (0%) 0 2/423 (0.5%) 2 0/212 (0%) 0 3/435 (0.7%) 3 0/217 (0%) 0 0/646 (0%) 0
    Feeling jittery 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 2/217 (0.9%) 2 0/646 (0%) 0
    Gait disturbance 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 1/217 (0.5%) 1 0/646 (0%) 0
    Malaise 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Mass 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Non-cardiac chest pain 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 0/217 (0%) 0 0/646 (0%) 0
    Peripheral swelling 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Pyrexia 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Sense of oppression 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Thirst 0/429 (0%) 0 1/225 (0.4%) 1 1/423 (0.2%) 2 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Infections and infestations
    Bronchitis 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Gastroenteritis 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Hordeolum 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Influenza 2/429 (0.5%) 2 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Laryngitis 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Nasopharyngitis 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 3/646 (0.5%) 3
    Rhinitis 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Sinusitis 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 1/212 (0.5%) 1 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Upper respiratory tract infection 3/429 (0.7%) 3 1/225 (0.4%) 1 2/423 (0.5%) 2 2/212 (0.9%) 2 3/435 (0.7%) 3 2/217 (0.9%) 2 3/646 (0.5%) 3
    Urinary tract infection 0/429 (0%) 0 1/225 (0.4%) 1 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Viral upper respiratory tract infection 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Injury, poisoning and procedural complications
    Arthropod sting 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Contusion 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Ligament sprain 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Skin abrasion 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Tendon injury 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Investigations
    Blood pressure decreased 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Blood pressure increased 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Heart rate increased 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 1/212 (0.5%) 1 1/435 (0.2%) 1 0/217 (0%) 0 1/646 (0.2%) 1
    Pulse pressure increased 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 2/646 (0.3%) 2
    Back pain 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 2/435 (0.5%) 2 1/217 (0.5%) 1 1/646 (0.2%) 1
    Muscle spasms 1/429 (0.2%) 1 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Muscle twitching 0/429 (0%) 0 0/225 (0%) 0 3/423 (0.7%) 3 0/212 (0%) 0 2/435 (0.5%) 2 2/217 (0.9%) 2 1/646 (0.2%) 1
    Muscular weakness 6/429 (1.4%) 6 1/225 (0.4%) 1 4/423 (0.9%) 4 4/212 (1.9%) 4 7/435 (1.6%) 7 2/217 (0.9%) 2 0/646 (0%) 0
    Musculoskeletal chest pain 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Musculoskeletal pain 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Musculoskeletal stiffness 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 1/646 (0.2%) 2
    Myalgia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Neck pain 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Pain in extremity 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Nervous system disorders
    Aphasia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Ataxia 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 0/217 (0%) 0 0/646 (0%) 0
    Aura 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Balance disorder 1/429 (0.2%) 1 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 2/435 (0.5%) 2 2/217 (0.9%) 2 0/646 (0%) 0
    Clumsiness 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Cognitive disorder 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 0/217 (0%) 0 0/646 (0%) 0
    Coordination abnormal 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 2/212 (0.9%) 2 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Disturbance in attention 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Dizziness 39/429 (9.1%) 42 18/225 (8%) 19 77/423 (18.2%) 84 45/212 (21.2%) 45 89/435 (20.5%) 94 33/217 (15.2%) 33 16/646 (2.5%) 17
    Dysaesthesia 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Dysarthria 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 2/212 (0.9%) 2 2/435 (0.5%) 2 1/217 (0.5%) 1 0/646 (0%) 0
    Dysgeusia 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 2/646 (0.3%) 2
    Facial spasm 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Formication 0/429 (0%) 0 0/225 (0%) 0 2/423 (0.5%) 3 2/212 (0.9%) 2 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Head discomfort 1/429 (0.2%) 1 1/225 (0.4%) 1 1/423 (0.2%) 1 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Headache 2/429 (0.5%) 2 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 3/435 (0.7%) 3 0/217 (0%) 0 1/646 (0.2%) 1
    Hypoaesthesia 2/429 (0.5%) 2 0/225 (0%) 0 5/423 (1.2%) 6 5/212 (2.4%) 5 10/435 (2.3%) 10 0/217 (0%) 0 2/646 (0.3%) 2
    Lethargy 7/429 (1.6%) 8 2/225 (0.9%) 2 4/423 (0.9%) 4 4/212 (1.9%) 4 7/435 (1.6%) 7 7/217 (3.2%) 7 1/646 (0.2%) 1
    Migraine 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Myoclonus 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Paraesthesia 11/429 (2.6%) 13 7/225 (3.1%) 7 21/423 (5%) 22 17/212 (8%) 17 30/435 (6.9%) 34 13/217 (6%) 14 6/646 (0.9%) 6
    Presyncope 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Psychomotor hyperactivity 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Sedation 1/429 (0.2%) 1 0/225 (0%) 0 2/423 (0.5%) 2 2/212 (0.9%) 2 2/435 (0.5%) 2 2/217 (0.9%) 2 0/646 (0%) 0
    Sensory disturbance 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 3/212 (1.4%) 3 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Somnolence 24/429 (5.6%) 25 11/225 (4.9%) 11 21/423 (5%) 21 10/212 (4.7%) 10 34/435 (7.8%) 36 12/217 (5.5%) 12 13/646 (2%) 13
    Stupor 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Syncope 1/429 (0.2%) 2 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Tremor 0/429 (0%) 0 1/225 (0.4%) 1 2/423 (0.5%) 2 0/212 (0%) 0 4/435 (0.9%) 4 2/217 (0.9%) 2 0/646 (0%) 0
    Vertigo cns origin 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Psychiatric disorders
    Abnormal dreams 2/429 (0.5%) 3 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Adjustment disorder 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Adjustment disorder with anxiety 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Anxiety 2/429 (0.5%) 2 1/225 (0.4%) 1 6/423 (1.4%) 6 0/212 (0%) 0 3/435 (0.7%) 3 1/217 (0.5%) 1 0/646 (0%) 0
    Burnout syndrome 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Confusional state 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Delirium 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Depersonalisation 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Depressed mood 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Disorientation 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 2/217 (0.9%) 2 1/646 (0.2%) 1
    Euphoric mood 2/429 (0.5%) 2 0/225 (0%) 0 5/423 (1.2%) 5 0/212 (0%) 0 2/435 (0.5%) 2 1/217 (0.5%) 1 0/646 (0%) 0
    Hallucination 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Hallucination, visual 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Hypervigilance 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Insomnia 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 3/435 (0.7%) 3 0/217 (0%) 0 0/646 (0%) 0
    Mental disorder 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Mental status changes 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Mood swings 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Nightmare 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Panic attack 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 1/217 (0.5%) 1 0/646 (0%) 0
    Panic reaction 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Restlessness 0/429 (0%) 0 2/225 (0.9%) 2 2/423 (0.5%) 2 3/212 (1.4%) 3 3/435 (0.7%) 3 0/217 (0%) 0 0/646 (0%) 0
    Sleep disorder 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Sleep terror 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Suicidal ideation 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Renal and urinary disorders
    Urinary incontinence 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Reproductive system and breast disorders
    Metrorrhagia 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 2/435 (0.5%) 2 0/217 (0%) 0 0/646 (0%) 0
    Ovarian cyst 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Postmenopausal haemorrhage 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Cough 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Dyspnoea 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Epistaxis 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Nasal congestion 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Nasal odour 0/429 (0%) 0 1/225 (0.4%) 1 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Oropharyngeal pain 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Paranasal sinus discomfort 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Respiratory tract congestion 1/429 (0.2%) 1 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Sinus congestion 0/429 (0%) 0 0/225 (0%) 0 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Throat tightness 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 0/429 (0%) 0 2/225 (0.9%) 2 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Pruritus 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1
    Pruritus generalised 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 0/646 (0%) 0
    Vascular disorders
    Circulatory collapse 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 0/212 (0%) 0 1/435 (0.2%) 1 0/217 (0%) 0 0/646 (0%) 0
    Flushing 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 1/435 (0.2%) 1 1/217 (0.5%) 1 2/646 (0.3%) 3
    Hot flush 2/429 (0.5%) 2 2/225 (0.9%) 2 1/423 (0.2%) 1 0/212 (0%) 0 0/435 (0%) 0 0/217 (0%) 0 3/646 (0.5%) 3
    Hypertension 0/429 (0%) 0 0/225 (0%) 0 0/423 (0%) 0 1/212 (0.5%) 1 0/435 (0%) 0 0/217 (0%) 0 1/646 (0.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02605174
    Other Study ID Numbers:
    • 16889
    • H8H-CD-LAHK
    • 2015-005689-40
    • COL MIG-302
    First Posted:
    Nov 16, 2015
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019