臨床研究等提出・公開システム

Date of registration	Sept. 11, 2019
Last modified on	Dec. 14, 2020
Trial ID	jRCT2080224865

Scientific 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
Public Title	H8H-JE-LAIH

Completion Date or Terminated date	Nov. 30, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Eli Lilly Japan K.K.
	Address	-
	Phone Number	+81-120-023-812
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		May. 30, 2019
Target Sample Size		880
Study Type		Interventional
Study Design	Study Design	A prospective, multicenter, randomized, double-blind, placebo-controlled Phase 2 study of Japanese adult patients suffering from migraine with or without aura.
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion 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 greater than or equal to 11. -Migraine onset before the age of 50 years. -History of 3-8 migraine attacks per month and less than 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.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Migraine
Intervention(s)		investigational material(s) Generic name etc : Lasmiditan INN of investigational material : Lasmiditan Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : lasmiditan 50 mg, 100 mg, and 200 mg or placebo administered by mouth for a migraine headache control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Percentage of Participants who are Pain Free (High Dose) [ Time Frame: 2 Hours Postdose ]
Secondary Outcome		efficacy -Percentage of Participants who are Pain Free in Each Dose Group [ Time Frame: 2 Hours Postdose ] -Percentage of Participants with Pain Relief [ Time Frame: 2 Hours Postdose ]

Primary Sponsor	Eli Lilly Japan K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Tokyo-Eki Center-building Clinic IRB
Address of IRB	Tokyo-Eki Center-building, 3-3-14, Nihombashi, Chuo-ku, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	April. 11, 2019

Secondary ID No.	NCT03962738
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194949
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	Dec. 14, 2020	(this page)	Changes
1	Sept. 12, 2019	Detail

List of change history