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Completed

NCT Number: NCT03962738

A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Takanoko Hospital, Matsuyama, Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
  • History of disabling migraine for at least 1 year.
  • Migraine Disability Assessment Test (MIDAS) score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.

Exclusion criteria

  • Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.
  • History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.
  • History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).
  • History of orthostatic hypotension with syncope.

Treatment and study plan

Lasmiditan

Drug

Administered orally

Other names: LY573144

Placebo

Drug

Administered orally

Primary outcomes

  1. Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)

    Time frame: 2 Hours Postdose

    Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.

Secondary outcomes

  1. Percentage of Participants Who Are Headache Pain Free in Each Dose Group

    Time frame: 2 Hours Postdose

    Percentage of participants who are headache pain free in each dose group at 2 hours postdose.

  2. Percentage of Participants With Headache Pain Relief

    Time frame: 2 Hours Postdose

    Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.

  3. Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine

    Time frame: 2 Hours Postdose

    Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose.

    Missing value at a particular time point was considered as "nonresponder."

  4. Percentage of Participants With 24-Hour Sustained Pain Freedom

    Time frame: 24 Hours Postdose

    Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.

  5. Percentage of Participants With 48-Hour Sustained Pain Freedom

    Time frame: 48 Hours Postdose

    Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.

  6. Percentage of Participants That Are Free of Phonophobia

    Time frame: 2 Hours Postdose

    Percentage of participants that are free of phonophobia at 2 hours postdose.

  7. Percentage of Participants That Are Free of Photophobia

    Time frame: 2 Hours Postdose

    Percentage of participants that are free of photophobia at 2 hours postdose.

  8. Percentage of Participants That Are Free of Nausea

    Time frame: 2 Hours Postdose

    Percentage of participants that are free of nausea at 2 hours postdose.

  9. Percentage of Participants That Are Free of Vomiting

    Time frame: 2 Hours Postdose

    Percentage of participants that are free of vomiting at 2 hours postdose.

  10. Percentage of Participants With Pain Freedom

    Time frame: 1 Hour Postdose

    Percentage of participants with pain freedom.

  11. Percentage of Participants With Headache Pain Relief

    Time frame: 1 Hour Postdose

    Percentage of participants with headache pain relief at 1 hour postdose.

  12. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)

    Time frame: 1 Hour Postdose

    Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.

  13. Percentage of Participants With No Disability

    Time frame: 1 Hour Postdose

    Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.

    Percentage of participants who are responders defined as score = 0 at 1 hours postdose.

  14. Percentage of Participants With No Disability

    Time frame: 2 Hours Postdose

    Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.

    Percentage of participants who are responders defined as score = 0 at 2 hours postdose.

  15. Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan

    Time frame: Baseline, 24 Hours Postdose

    The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.

  16. Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale

    Time frame: Baseline, 24 Hours Postdose

    The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).

  17. Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)

    Time frame: 2 Hours Postdose

    The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.

  18. Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)

    Time frame: 24 Hours Postdose

    The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study

Acronym: MONONOFU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 24, 2019
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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