UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029846 |
|---|---|
| Receipt number | R000034062 |
| Scientific Title | A clinical study on efficacy of combination therapy of triptan agent and anti-epileptic drug in patients with severe migraine seizures |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2017/11/06 19:07:31 |
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Basic information
Public title
A clinical study on efficacy of combination therapy of triptan agent and anti-epileptic drug in patients with severe migraine seizures
Acronym
Combination therapy of triptan agent and anti-epileptic drug in migraine
Scientific Title
A clinical study on efficacy of combination therapy of triptan agent and anti-epileptic drug in patients with severe migraine seizures
Scientific Title:Acronym
Combination therapy of triptan agent and anti-epileptic drug in migraine
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore optimal therapy for severe migraine seizures by using combination of triptan agent (e.g. rizatriptan benzoate) with anti-epileptic drug (e.g. perampanel hydrate).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean of time to relieve seizures
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rizatriptan benzoate 10mg per dose at onset of
acute migraine seizures
Sodium loxoprofen 60mg per dose as anhydrate, orally twice a day
Perampanel hydrate 2mg per dose, once a daily at bedtime
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target subjects should be met the following inclusion criteria:
1) Subjects aged 20 or over when getting their informed consent
2) Subjects diagnosed as migraine by the ICHD-III (beta)
3) Subjects experiencing use of triptan agents for at least 3 months or over
4) Subjects experiencing use of either non-steroid inflammatory drugs (e.g. Sodium loxoprofen) or anti-epileptic drugs (e.g. sodium valproate, perampanel hydrate) for at least 3 month or over
5) Subjects suffering from seizures once a month or over in the past year
6) Self-informed consent possible
Key exclusion criteria
Exclusion criteria are:
1) Subjects diagnosed secondary headache
2) Subjects judged to be inappropriate as a study subject by the key investigator or sub-investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiichi Kawamata |
Organization
Tokyo Women's Medical University
Division name
Neurosurgery
Zip code
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
03-33533-1111
tkawamata@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shimizu |
Organization
Tokyo Women's Medical University
Division name
Neurosurgery
Zip code
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
03-33533-1111
Homepage URL
headache.shimizu@k4.dion.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Pharmaceutical Science, Teikyo Heisei University
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 13 | 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 | 11 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034062
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
