UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study on efficacy of combination therapy of triptan agent and anti-epileptic drug in patients with severe migraine seizures
Title of the study (Brief title)	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	Kiichi Kawamata
Organization	Tokyo Women's Medical University
Division name	Neurosurgery
Address	8-1 Kawada-cho Shinjuku-ku Tokyo
TEL	03-33533-1111
Email	tkawamata@twmu.ac.jp

Public contact
Name of contact person	Toshihiko Shimizu
Organization	Tokyo Women's Medical University
Division name	Neurosurgery
Address	8-1 Kawada-cho Shinjuku-ku Tokyo
TEL	03-33533-1111
Homepage URL
Email	headache.shimizu@k4.dion.ne.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034062