臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 29, 2024
Last modified on	Mar. 29, 2024
Trial ID	jRCT2051230212

Scientific Title	A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age
Public Title	A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

Contact for Scientific Queries	Name	Otani Tetsuya
	Affiliation	AbbVie G.K.
	Address	3-1-21, Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com
Contact for Public Queries	Name	Patients and HCP Contact
	Affiliation	AbbVie G.K.
	Address	3-1-21, Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 29, 2024
Target sample size		450
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs). History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months. Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
	Exclusion Criteria	History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018). Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.
	Age Minimum	6age old over
	Age Maximum	17age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Episodic migraine
Intervention(s)		Atogepant Oral Tablet or Placebo-Matching Atogepant Oral Tablet for 12 weeks
Primary Outcome(s)		Change from Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through Week 12 ]

Primary Sponsor	AbbVie GK

Name of Certified Review Board	Tominaga Hospital Institutional Review Board
Address	2-2-14, Shikitsunishi, Naniaku, Osaka, Osaka
Approval Status	Approval
Date of approval	July. 12, 2023

Plan to share IPD	Yes
Plan description	AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Plan to share IPD

Yes

Plan description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Countries of Recruitment（Except Japan）	Belgium/Canada/Denmark/France/Hungary/Israel/Italy/Netherlands/Poland/Puerto Rico/Romania/Spain/Sweden/United Kingdom/United States