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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006703
Receipt No. R000006498
Scientific Title A study on new antiepileptic drug levetiracetam in patients with epilepsy surgery
Date of disclosure of the study information 2011/11/11
Last modified on 2011/11/11

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Basic information
Public title A study on new antiepileptic drug levetiracetam in patients with epilepsy surgery
Acronym A study on new antiepileptic drug levetiracetam in patients with epilepsy surgery
Scientific Title A study on new antiepileptic drug levetiracetam in patients with epilepsy surgery
Scientific Title:Acronym A study on new antiepileptic drug levetiracetam in patients with epilepsy surgery
Region
Japan

Condition
Condition epilepsy
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the long-term efficacy and safety of levetiracetam on pre- and post-operative seizures in patients with epilepsy surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Long-term tolerability of levetiracetam in patients with epilepsy surgery
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pharmacoresistent partial seizures.
Patients with a planning or already performed epileptic surgery.
Patients on medication with more than one antiepileptic drugs.
Patients given a written informed consent.
Key exclusion criteria Patients already administered levetiracetam before starting the test drugs.
Patients with a history of hypersensitivity for ingredients of the test drugs or pyrrolidone derivatives.
Patients with psychiatric disease, progressive neurological disorder and other serious complications.
Patients during administering other investigational or unapproved drugs within three months before starting a follow-up.
Patients with clinical trials of levetiracetam in the past.
Patients with levetiracetam discontinued because of the side effects in the past.
Patients with non (or potential of non)-compliance to regular medication or doctor consultation appointments. Pregnant or potentially pregnant women, breast-feeding women.
Patients considered to be inappropriative for carrying out the trials by attending physicians.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Iida
Organization Graduates School of Biomedical Sciences, Hiroshima University
Division name Department of Neurosurgery
Zip code
Address 1-2-3 Kasumi Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduates School of Biomedical Sciences, Hiroshima University
Division name Department of Neurosurgery
Zip code
Address 1-2-3 Kasumi Minami-ku, Hiroshima
TEL
Homepage URL
Email

Sponsor
Institute Graduates School of Biomedical Sciences, Department of Neurosurgery, Hiroshima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 広島大学病院、広島大学大学院医歯薬学総合研究科

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 11 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 Enrolling by invitation
Date of protocol fixation
2011 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2011 Year 11 Month 11 Day
Last modified on
2011 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006498

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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