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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006186
Receipt No. R000007318
Scientific Title The clinical study for effectiveness and safeness of levetiracetam combination therapy for symptomatic seizure
Date of disclosure of the study information 2011/09/01
Last modified on 2014/10/07

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Basic information
Public title The clinical study for effectiveness and safeness of levetiracetam combination therapy for symptomatic seizure
Acronym The effectiveness of levetiracetam combination therapy
Scientific Title The clinical study for effectiveness and safeness of levetiracetam combination therapy for symptomatic seizure
Scientific Title:Acronym The effectiveness of levetiracetam combination therapy
Region
Japan

Condition
Condition symptomatic intractable epilepsy
Classification by specialty
Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of combination therapy of levetilacetam for intractable epilepsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes disppearace rate of attack
reduction rate of attack frequency
Key secondary outcomes QOLIE-31

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Medication of levetiracetum
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The intended patients which have symptomatic intractable epilepsy due to brain tumor,apoplexy and brain trauma.
they have already taken other existing other anti-epileptic drugs.

Key exclusion criteria The pateints which can not be estimated the attack frequency during study peroid and with serious liver dysfunction, renal dysfunaction, severe brain vascular disease, brain tumor or metal disfunction.
A women with pregnacy or a possibility of pregnacy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kinouchi
Organization Faculity of Meidison, Yamanashi Univiersity
Division name Department of Neurosurgery
Zip code
Address Shimokato1110, Chuo, Yamanashi
TEL 055-243-6786
Email kawataki@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kawataki Tomoyuki
Organization Faculity of Meidison, Yamanashi Univiersity
Division name Department of Neurosurgery
Zip code
Address Shimokato1110, Chuo, Yamanashi
TEL 055-243-6786
Homepage URL
Email kawataki@yamanashi.ac.jp

Sponsor
Institute Yamanashi Univiersity
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
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
2011 Year 09 Month 01 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
2011 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 07 Day
Date trial data considered complete
2014 Year 10 Month 07 Day
Date analysis concluded
2014 Year 10 Month 07 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 17 Day
Last modified on
2014 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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