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

Migraine Clinical Trial

— MONONOFU  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962738
• Other study ID #: 17012
• Secondary ID: H8H-JE-LAIH
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: May 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: June 8, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Lasmiditan
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Japan	Niwa Family Clinic	Chofu-shi	Tokyo
Japan	Doi Clinic Internal Medicine Neurology	Hiroshima
Japan	Saitama Medical University Hospital	Iruma-Gun	Saitama
Japan	Tanaka neurosurgical clinic	Kagoshima
Japan	Nagaseki Headache Clinic	Kai-Shi	Yamanashi
Japan	Ikeda Neurosurgical Clinic	Kasuga-shi	Fukuoka
Japan	Jinnouchi Neurosurgery Clinic	Kasuga-shi	Fukuoka
Japan	Fujitsu Clinic	Kawasaki	Kanagawa
Japan	Kohnan Hospital	Kobe	Hyogo
Japan	Umenotsuji Clinic	Kochi
Japan	Kumamoto City Hospital	Kumamoto
Japan	Ishikawa Clinic	Kyoto
Japan	Tatsuoka Neurology Clinic	Kyoto
Japan	Takanoko Hospital	Matsuyama-shi	Ehime
Japan	Sanno Clinic Shinagawa	Minato-ku	Tokyo
Japan	Nishinomiya Municipal Central Hospital	Nishinomiya	Hyogo
Japan	Yamaguchi Clinic	Nishinomiya-shi	Hyogo
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama-shi	Okayama
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Tominaga Hospital	Osaka
Japan	Chibune General Hospital	Osaka-City	Osaka
Japan	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma
Japan	Osoegawa Neurology Clinic	Saga-shi	Saga
Japan	Saitama Neuropsychiatric Institute	Saitama City	Saitama
Japan	Nakamura Memorial Hospital	Sapporo	Hokkaido
Japan	Sendai Headache and Neurology Clinic	Sendai	Miyagi
Japan	USUDA CLINIC for internal medicine	Setagaya-ku	Tokyo
Japan	Tokyo Headache Clinic	Shibuya-ku	Tokyo
Japan	Dokkyo Medical University Hospital	Shimotsuga-Gun	Tochigi
Japan	Fukuuchi Pain Clinic	Shinjuku-ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka
Japan	Saino Clinic	Tokorozawa	Saitama
Japan	Sakura Clinic Internal Medicine Neurology	Toyama-Shi	Toyama
Japan	Takase internal medicine clinic	Toyonaka-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)	Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants Who Are Headache Pain Free in Each Dose Group	Percentage of participants who are headache pain free in each dose group at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants With Headache Pain Relief	Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine	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."	2 Hours Postdose
Secondary	Percentage of Participants With 24-Hour Sustained Pain Freedom	Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.	24 Hours Postdose
Secondary	Percentage of Participants With 48-Hour Sustained Pain Freedom	Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.	48 Hours Postdose
Secondary	Percentage of Participants That Are Free of Phonophobia	Percentage of participants that are free of phonophobia at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants That Are Free of Photophobia	Percentage of participants that are free of photophobia at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants That Are Free of Nausea	Percentage of participants that are free of nausea at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants That Are Free of Vomiting	Percentage of participants that are free of vomiting at 2 hours postdose.	2 Hours Postdose
Secondary	Percentage of Participants With Pain Freedom	Percentage of participants with pain freedom.	1 Hour Postdose
Secondary	Percentage of Participants With Headache Pain Relief	Percentage of participants with headache pain relief at 1 hour postdose.	1 Hour Postdose
Secondary	Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)	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.	1 Hour Postdose
Secondary	Percentage of Participants With No Disability	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.	1 Hour Postdose
Secondary	Percentage of Participants With No Disability	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.	2 Hours Postdose
Secondary	Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan	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.	Baseline, 24 Hours Postdose
Secondary	Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale	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).	Baseline, 24 Hours Postdose
Secondary	Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)	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.	2 Hours Postdose
Secondary	Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)	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.	24 Hours Postdose