Clinical trial NCT03962738: A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
timeFrame: 2 Hours Postdose
Secondary outcomes:
measure: Percentage of Participants Who Are Headache Pain Free in Each Dose Group
timeFrame: 2 Hours Postdose
measure: Percentage of Participants With Headache Pain Relief
timeFrame: 2 Hours Postdose
measure: Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
timeFrame: 2 Hours Postdose
measure: Percentage of Participants With 24-Hour Sustained Pain Freedom
timeFrame: 24 Hours Postdose
measure: Percentage of Participants With 48-Hour Sustained Pain Freedom
timeFrame: 48 Hours Postdose
measure: Percentage of Participants That Are Free of Phonophobia
timeFrame: 2 Hours Postdose
measure: Percentage of Participants That Are Free of Photophobia
timeFrame: 2 Hours Postdose
measure: Percentage of Participants That Are Free of Nausea
timeFrame: 2 Hours Postdose
measure: Percentage of Participants That Are Free of Vomiting
timeFrame: 2 Hours Postdose
measure: Percentage of Participants With Pain Freedom
timeFrame: 1 Hour Postdose
measure: Percentage of Participants With Headache Pain Relief
timeFrame: 1 Hour Postdose
measure: Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
timeFrame: 1 Hour Postdose
measure: Percentage of Participants With No Disability
timeFrame: 1 Hour Postdose
measure: Percentage of Participants With No Disability
timeFrame: 2 Hours Postdose
measure: Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
timeFrame: Baseline, 24 Hours Postdose
measure: Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
timeFrame: Baseline, 24 Hours Postdose
measure: Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
timeFrame: 2 Hours Postdose
measure: Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
timeFrame: 24 Hours Postdose
Other outcomes:
Locations:
city: Matsuyama-shi
country: Japan
facility: Takanoko Hospital
state: Ehime
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgical Clinic
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgery Clinic
state: Fukuoka
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kohnan Hospital
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Yamaguchi Clinic
state: Hyogo
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Kawasaki
country: Japan
facility: Fujitsu Clinic
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
state: Okayama
city: Osaka-City
country: Japan
facility: Chibune General Hospital
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Takase internal medicine clinic
state: Osaka
city: Saga-shi
country: Japan
facility: Osoegawa Neurology Clinic
state: Saga
city: Iruma-Gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Saitama City
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Tokorozawa
country: Japan
facility: Saino Clinic
state: Saitama
city: Shimotsuga-Gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Chofu-shi
country: Japan
facility: Niwa Family Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Sanno Clinic Shinagawa
state: Tokyo
city: Setagaya-ku
country: Japan
facility: USUDA CLINIC for internal medicine
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Fukuuchi Pain Clinic
state: Tokyo
city: Toyama-Shi
country: Japan
facility: Sakura Clinic Internal Medicine Neurology
state: Toyama
city: Kai-Shi
country: Japan
facility: Nagaseki Headache Clinic
state: Yamanashi
city: Hiroshima
country: Japan
facility: Doi Clinic Internal Medicine Neurology
city: Kagoshima
country: Japan
facility: Tanaka neurosurgical clinic
city: Kochi
country: Japan
facility: Umenotsuji Clinic
city: Kumamoto
country: Japan
facility: Kumamoto City Hospital
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic
city: Kyoto
country: Japan
facility: Ishikawa Clinic
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Osaka
country: Japan
facility: Tominaga Hospital
city: Shizuoka
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Matsumori Y, Komori M, Tanji Y, Ozeki A, Sakai F. Rapid Onset and Sustained Efficacy of Lasmiditan Among Japanese Patients with Migraine: Prespecified Analyses of a Randomized Controlled Trial. Neurol Ther. 2022 Dec;11(4):1721-1734. doi: 10.1007/s40120-022-00403-2. Epub 2022 Sep 22.
citation: MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
citation: Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
citation: Hashimoto Y, Komori M, Tanji Y, Ozeki A, Hirata K. Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial. Expert Opin Drug Saf. 2022 Dec;21(12):1495-1503. doi: 10.1080/14740338.2022.2078302. Epub 2022 Jun 24.
citation: Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.