UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of CGS-1 in Migraine Female Volunteers: Randomized, Single-blind, Placebo-controlled, Crossover Trial
Title of the study (Brief title)	Efficacy of CGS-1 in Migraine
Region	Japan

Condition
Condition	Migraine
Classification by specialty	Neurology Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy of CGS-1 for female migraine without aura.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in NRS (Numerical Rating Scale) from the start of the test to 30 minutes later.
Key secondary outcomes	1)Change in NRS (Numerical Rating Scale) at 60 minutes, 120 minutes and 180 minutes after the start of the test. 2)Changes in daily disability assessment HIT (Headache Impact Test) - 6

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the CGS-1 for forehead for 2 hours.
Interventions/Control_2	Apply the placebo for forehead for 2 hours.
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	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	1)Women aged 20-49. 2)Subjects with migraine without aura experience three to five migraine per month. 3)Subjects with lucidity and no intellectual disability can communicate. 4)Written informed consent. 5)If migraine and tension type headache are merged, the subjects can distinguish between the two.
Key exclusion criteria	1)Subjects with migraine with aura 2)Subjects with the headache without migraine 3)Subjects with taking triptan medicine. 4)Subjects with the hemicrania continua. 5)Subjects with pregnancies and lactations. 6)Subjects with atopic dermatitis. 7)Subjects with vulnerable to skin irritation by menthol or alcohol. 8)Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Nobuyasu Kimura
Organization	Tokyo Clinic
Division name	Pain Clinic of Internal Medicine
Address	2-2-1, Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL	03-3516-7151
Email	kimukimu1234@hotmail.co.jp

Public contact
Name of contact person	Nobuyasu Kimura
Organization	Tokyo Clinic
Division name	Pain Clinic of Internal Medicines
Address	2-2-1, Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL	03-3516-7151
Homepage URL
Email	kimukimu1234@hotmail.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	医療法人財団　健貢会 東京クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2018 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032985