臨床研究等提出・公開システム

Date of registration	Sept. 11, 2019
Last modified on	Dec. 14, 2021
Trial ID	jRCT2080224864

Scientific Title	A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients with Migraine
Public Title	H8H-MC-LAHX

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		Aug. 02, 2019
Target Sample Size		21
Study Type		Interventional
Study Design	Study Design	A Phase 1, multicenter, open-label, single-dose study to determine the PK, safety, and tolerability of lasmiditan in pediatric patients with a diagnosis of migraine.
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Participants must have a history of migraine headaches for more than 6 months -Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months -Participants must weigh between 15 and 55 kilograms (kg) -Participants must not have a migraine headache on the day of lasmiditan administration
	Exclusion Criteria	-Participants must not be pregnant or nursing -Participants must not have any acute, serious, or unstable medical condition -Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator -Participants must not be on a medicine that acts in the brain and spinal cord
	Minimum Age	6age old over
	Maximum Age	17age old under
	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 : Single dose of lasmiditan 100 mg or 200 mg administered orally 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		pharmacokinetics Pharmacokinetics of Lasmiditan in pediatric migraine patients following a single oral dose of lasmiditan.
Secondary Outcome		safety other Safety and Tolerability of Lasmiditan in pediatric migraine patients following a single oral dose of lasmiditan.

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

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IHL Shinagawa East One Medical Clinic IRB
Address of IRB	East One Tower 3F, 2-16-1 Kounan, Minato-ku, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	June. 13, 2019

Secondary ID No.	NCT03988088
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194948
Name of Other Registries

Countries / Regions of Recruitment	North America/Japan

History of Changes

No	Publication date
2	Dec. 14, 2021	(this page)	Changes
1	Sept. 12, 2019	Detail

List of change history