UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028919
Receipt No. R000032985
Scientific Title Efficacy of CGS-1 in Migraine Female Volunteers: Randomized, Single-blind, Placebo-controlled, Crossover Trial
Date of disclosure of the study information 2017/09/24
Last modified on 2018/04/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of CGS-1 in Migraine Female Volunteers: Randomized,
Single-blind, Placebo-controlled, Crossover Trial
Acronym Efficacy of CGS-1 in Migraine
Scientific Title Efficacy of CGS-1 in Migraine Female Volunteers: Randomized,
Single-blind, Placebo-controlled, Crossover Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Nobuyasu Kimura
Organization Tokyo Clinic
Division name Pain Clinic of Internal Medicine
Zip code
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
1st name
Middle name
Last name Nobuyasu Kimura
Organization Tokyo Clinic
Division name Pain Clinic of Internal Medicines
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.