A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
- Registration Number
- NCT03962738
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 846
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 milligram (mg) Lasmiditan Placebo 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. 100 mg Lasmiditan Placebo 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. 200 mg Lasmiditan Placebo 200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack. Placebo Placebo Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. 100 mg Lasmiditan Lasmiditan 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. 50 milligram (mg) Lasmiditan Lasmiditan 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. 200 mg Lasmiditan Lasmiditan 200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) 2 Hours Postdose Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Headache Pain Relief 1 Hour Postdose Percentage of participants with headache pain relief at 1 hour postdose.
Percentage of Participants Who Are Headache Pain Free in Each Dose Group 2 Hours Postdose Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine 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."Percentage of Participants With 24-Hour Sustained Pain Freedom 24 Hours Postdose Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Percentage of Participants With 48-Hour Sustained Pain Freedom 48 Hours Postdose Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Percentage of Participants That Are Free of Phonophobia 2 Hours Postdose Percentage of participants that are free of phonophobia at 2 hours postdose.
Percentage of Participants That Are Free of Photophobia 2 Hours Postdose Percentage of participants that are free of photophobia at 2 hours postdose.
Percentage of Participants That Are Free of Nausea 2 Hours Postdose Percentage of participants that are free of nausea at 2 hours postdose.
Percentage of Participants That Are Free of Vomiting 2 Hours Postdose Percentage of participants that are free of vomiting at 2 hours postdose.
Percentage of Participants With Pain Freedom 1 Hour Postdose Percentage of participants with pain freedom.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) 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.
Percentage of Participants With No Disability 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.Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan 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.
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale 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).
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) 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.
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) 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.
Trial Locations
- Locations (34)
Osaka Saiseikai Nakatsu Hospital
🇯🇵Osaka, Japan
Tominaga Hospital
🇯🇵Osaka, Japan
Kohnan Hospital
🇯🇵Kobe, Hyogo, Japan
Saino Clinic
🇯🇵Tokorozawa, Saitama, Japan
Ikeda Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
Takanoko Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
Jinnouchi Neurosurgery Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
🇯🇵Ota-shi, Gunma, Japan
Osoegawa Neurology Clinic
🇯🇵Saga-shi, Saga, Japan
Nakamura Memorial Hospital
🇯🇵Sapporo, Hokkaido, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya-shi, Hyogo, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Fujitsu Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Sendai Headache and Neurology Clinic
🇯🇵Sendai, Miyagi, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama-shi, Okayama, Japan
Chibune General Hospital
🇯🇵Osaka-City, Osaka, Japan
Takase internal medicine clinic
🇯🇵Toyonaka-shi, Osaka, Japan
Saitama Medical University Hospital
🇯🇵Iruma-Gun, Saitama, Japan
Saitama Neuropsychiatric Institute
🇯🇵Saitama City, Saitama, Japan
Niwa Family Clinic
🇯🇵Chofu-shi, Tokyo, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-Gun, Tochigi, Japan
Fukuuchi Pain Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Headache Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
USUDA CLINIC for internal medicine
🇯🇵Setagaya-ku, Tokyo, Japan
Sanno Clinic Shinagawa
🇯🇵Minato-ku, Tokyo, Japan
Sakura Clinic Internal Medicine Neurology
🇯🇵Toyama-Shi, Toyama, Japan
Nagaseki Headache Clinic
🇯🇵Kai-Shi, Yamanashi, Japan
Tanaka neurosurgical clinic
🇯🇵Kagoshima, Japan
Doi Clinic Internal Medicine Neurology
🇯🇵Hiroshima, Japan
Umenotsuji Clinic
🇯🇵Kochi, Japan
Ishikawa Clinic
🇯🇵Kyoto, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto, Japan
Kumamoto City Hospital
🇯🇵Kumamoto, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka, Japan