A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
MONONOFU
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
2 other identifiers
interventional
846
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
May 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2020
CompletedResults Posted
Study results publicly available
May 5, 2021
CompletedJune 11, 2021
May 1, 2021
1 year
May 23, 2019
April 9, 2021
May 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Percentage of Participants Who Are Headache Pain Free in Each Dose Group
2 Hours Postdose
Percentage of Participants With Headache Pain Relief
2 Hours Postdose
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
2 Hours Postdose
Percentage of Participants With 24-Hour Sustained Pain Freedom
24 Hours Postdose
Percentage of Participants With 48-Hour Sustained Pain Freedom
48 Hours Postdose
- +13 more secondary outcomes
Study Arms (4)
50 milligram (mg) Lasmiditan
EXPERIMENTAL50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
100 mg Lasmiditan
EXPERIMENTAL100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
200 mg Lasmiditan
EXPERIMENTAL200 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 COMPARATORPlacebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Takanoko Hospital
Matsuyama, Ehime, 790-0925, Japan
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816 0824, Japan
Jinnouchi Neurosurgery Clinic
Kasuga-shi, Fukuoka, 816-0802, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060 8570, Japan
Kohnan Hospital
Kobe, Hyōgo, 658-0064, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, Hyōgo, 663-8014, Japan
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, 663-8204, Japan
Fujitsu Clinic
Kawasaki, Kanagawa, 211-8588, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557, Japan
Chibune General Hospital
Osaka, Osaka, 555-0034, Japan
Takase internal medicine clinic
Toyonaka-shi, Osaka, 560-0012, Japan
Osoegawa Neurology Clinic
Saga, Saga-ken, 840-0806, Japan
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495, Japan
Saitama Neuropsychiatric Institute
Saitama, Saitama, 338-8577, Japan
Saino Clinic
Tokorozawa, Saitama, 359-1141, Japan
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, 321 0293, Japan
Niwa Family Clinic
Chofu-shi, Tokyo, 182-0006, Japan
Sanno Clinic Shinagawa
Minato-ku, Tokyo, 108-0075, Japan
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, 156-0043, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, 160-0017, Japan
Sakura Clinic Internal Medicine Neurology
Toyama, Toyama, 9300803, Japan
Nagaseki Headache Clinic
Kai-Shi, Yamanashi, 400-0124, Japan
Doi Clinic Internal Medicine Neurology
Hiroshima, 730-0031, Japan
Tanaka neurosurgical clinic
Kagoshima, 892-0844, Japan
Umenotsuji Clinic
Kochi, 780-8011, Japan
Kumamoto City Hospital
Kumamoto, 862-8505, Japan
Tatsuoka Neurology Clinic
Kyoto, 600-8811, Japan
Ishikawa Clinic
Kyoto, 606-0851, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, 530-0012, Japan
Tominaga Hospital
Osaka, 5560017, Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, 420-0853, Japan
Related Publications (6)
Kitamura S, Imai N, Tanji Y, Ozeki A, Komori M. Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study. J Pain Res. 2023 May 25;16:1725-1738. doi: 10.2147/JPR.S399567. eCollection 2023.
PMID: 37255987DERIVEDMatsumori 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.
PMID: 36136232DERIVEDMacGregor 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.
PMID: 35979677DERIVEDDoty 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.
PMID: 35779194DERIVEDHashimoto 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.
PMID: 35748397DERIVEDKrege 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.
PMID: 35471625DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 24, 2019
Study Start
May 31, 2019
Primary Completion
June 8, 2020
Study Completion
June 8, 2020
Last Updated
June 11, 2021
Results First Posted
May 5, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.