UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007036
Receipt number R000008245
Scientific Title Prospective Post-marketing Surveillance of Sodium Valproate (SELENICA-R) in migraine patients
Date of disclosure of the study information 2012/01/15
Last modified on 2012/11/19 17:22:16

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Basic information

Public title

Prospective Post-marketing Surveillance of Sodium Valproate (SELENICA-R) in migraine patients

Acronym

Prospective Post-marketing Surveillance of Sodium Valproate (SELENICA-R) in migraine patients

Scientific Title

Prospective Post-marketing Surveillance of Sodium Valproate (SELENICA-R) in migraine patients

Scientific Title:Acronym

Prospective Post-marketing Surveillance of Sodium Valproate (SELENICA-R) in migraine patients

Region

Japan


Condition

Condition

migraine

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To survey its safety and validity of SELENICA-R for migraine subjects under clinical practice setting

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Alteration of migraine days and attack frequency
2)Improvement factor

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patient who fulfills all the following conditions. Age is unquestioned.
1) The patient whose daily activity is inhibited although some acute treatment for migraine attack.
2) The patient who has 2 or more migraine attacks per month.
3) The patient who has not been exposed Sodium Valproate for past one year.
4) The patient whose situation of his/her migraine headache can be clearly described at least four weeks before the start of medication.
5) The patient who has not be prescribed any prophylaxis medication during three-month before the start of medication, or has not changed the prophylaxis medication.

Key exclusion criteria

None

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Takeshima

Organization

Tominaga Hospital

Division name

Department of Neurology, Headache Center

Zip code


Address

1-4-48 MInatomachi, Naniwa-ku, Osaka 556-0017

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takao Takeshima

Organization

Tominaga Hospital

Division name

Department of Neurology, Headache Center

Zip code


Address


TEL

06-6568-1601

Homepage URL


Email



Sponsor or person

Institute

KOWA Co.Ltd

Institute

Department

Personal name



Funding Source

Organization

KOWA Co.Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 15 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

No longer recruiting

Date of protocol fixation

2011 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 06 Month 01 Day

Date trial data considered complete

2013 Year 06 Month 01 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information

N/A


Management information

Registered date

2012 Year 01 Month 08 Day

Last modified on

2012 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name