UMIN-CTR Clinical Trial

Basic information
Public title	The effect of anti-CGRP antibody treatment on migraine aura symptoms
Acronym	The effect of anti-CGRP antibody treatment on migraine aura symptoms
Scientific Title	The effect of anti-CGRP antibody treatment on migraine aura symptoms
Scientific Title:Acronym	The effect of anti-CGRP antibody treatment on migraine aura symptoms
Region	Japan

Condition
Condition	Migraine with aura
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the improvement of aura symptoms of migraine with Galcanezumab treatment
Basic objectives2	Others
Basic objectives -Others	To investigate the improvement of aura symptoms of migraine with Galcanezumab treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in visual aura frequency per 3 months after 6 months treatment with Galcanezumab
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patients who fulfill International Headache Classification 3rd Edition criteria of 1.2 migraine with Aura 2) Patients with visual aura occurring an average of 1 or more times per 3 months over the last one year 3) Inpatients or outpatients 4) Patients with written informed consent.
Key exclusion criteria	1) Patients with secondary headache except for medication overuse headache 2) Patients with trigeminal autonomic cephalalgias (TACs)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name TAKESHIMA
Organization	Tominaga Hospital
Division name	Headache center, Department of neurology
Zip code	5560017
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
TEL	06-6568-1601
Email	ttakeshi@tominaga.or.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name DANNO
Organization	Tominaga Hospital
Division name	Headache center, Department of neurology
Zip code	5560017
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
TEL	06-6568-1601
Homepage URL
Email	daisuke_danno@yahoo.co.jp

Sponsor
Institute	Tominaga Hospital
Institute
Department

Funding Source
Organization	Nil
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tominaga Hospital Ethics committee
Address	1-4-48 Minatomachi, Naniwa-ku, Osaka-city, Osaka, Japan
Tel	06-6568-1601
Email	imura@tominaga.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2021 Year 04 Month 06 Day
Date of IRB	2021 Year 06 Month 09 Day
Anticipated trial start date	2021 Year 06 Month 21 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Terminated

Management information
Registered date	2021 Year 06 Month 19 Day
Last modified on	2022 Year 06 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050940