UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006186 |
|---|---|
| Receipt number | 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 21:21:17 |
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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
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
kawataki@yamanashi.ac.jp
Sponsor or person
Institute
Yamanashi Univiersity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007318
| 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 |
