UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028919 |
|---|---|
| Receipt number | 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 21:36:56 |
* 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
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
kimukimu1234@hotmail.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032985
