UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006703 |
|---|---|
| Receipt number | 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 12:18:21 |
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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
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
Sponsor or person
Institute
Graduates School of Biomedical Sciences, Department of Neurosurgery, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006498
