A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
NCT ID: NCT03962738
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
846 participants
INTERVENTIONAL
2019-05-31
2020-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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50 milligram (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
Lasmiditan
Administered orally
Placebo
Administered orally
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
Lasmiditan
Administered orally
Placebo
Administered orally
200 mg 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.
Lasmiditan
Administered orally
Placebo
Administered orally
Placebo
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
Placebo
Administered orally
Interventions
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Lasmiditan
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Takanoko Hospital
Matsuyama, Ehime, Japan
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, Japan
Jinnouchi Neurosurgery Clinic
Kasuga-shi, Fukuoka, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kohnan Hospital
Kobe, Hyōgo, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, Hyōgo, Japan
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, Japan
Fujitsu Clinic
Kawasaki, Kanagawa, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, Japan
Chibune General Hospital
Osaka, Osaka, Japan
Takase internal medicine clinic
Toyonaka-shi, Osaka, Japan
Osoegawa Neurology Clinic
Saga, Saga-ken, Japan
Saitama Medical University Hospital
Iruma-Gun, Saitama, Japan
Saitama Neuropsychiatric Institute
Saitama, Saitama, Japan
Saino Clinic
Tokorozawa, Saitama, Japan
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, Japan
Niwa Family Clinic
Chofu-shi, Tokyo, Japan
Sanno Clinic Shinagawa
Minato-ku, Tokyo, Japan
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, Japan
Sakura Clinic Internal Medicine Neurology
Toyama, Toyama, Japan
Nagaseki Headache Clinic
Kai-Shi, Yamanashi, Japan
Doi Clinic Internal Medicine Neurology
Hiroshima, , Japan
Tanaka neurosurgical clinic
Kagoshima, , Japan
Umenotsuji Clinic
Kochi, , Japan
Kumamoto City Hospital
Kumamoto, , Japan
Tatsuoka Neurology Clinic
Kyoto, , Japan
Ishikawa Clinic
Kyoto, , Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, , Japan
Tominaga Hospital
Osaka, , Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, , Japan
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H8H-JE-LAIH
Identifier Type: OTHER
Identifier Source: secondary_id
17012
Identifier Type: -
Identifier Source: org_study_id
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