UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017531 |
|---|---|
| Receipt number | R000020318 |
| Scientific Title | Evaluation of the effect of the antiepiletic levetiracetum on seizure control and expression of MGMT in patients with gliomas (Phase II clinical trial) |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2015/11/13 12:19:41 |
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Basic information
Public title
Evaluation of the effect of the antiepiletic levetiracetum on seizure control and expression of MGMT in patients with gliomas (Phase II clinical trial)
Acronym
LEV for Glioma
Scientific Title
Evaluation of the effect of the antiepiletic levetiracetum on seizure control and expression of MGMT in patients with gliomas (Phase II clinical trial)
Scientific Title:Acronym
LEV for Glioma
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of LEV on perioperative seizure control and expression of MGMT in patients with gliomas (grade I-IV)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-months retention rate of LEV
Key secondary outcomes
Expression of MGMT (by immunohistochemistry)
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with gliomas without history of radiotherapy or chemotherapy
2. Age >=20
3. ECOG PS=0,1,2 or 3 (by neurological deficit due to glioma)
4. Meet the criteria of blood test (neutrophil, Hb, Plt, AST, ALT. Total bilirubin, Serum Creatinine)
5. Written informed consent
Key exclusion criteria
1. History of allergy to the ingredients of levetiracetum or pyrrolidones
2. History of status epilepticus or intractable epilepsy
3. Serious psychotic disorder
4. Pregnant or breast feeding women
5. Severe heart disease, or liver dysfunction, or renal dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hikaru Sasaki |
Organization
Keio University School of Medicine
Division name
Neurosurgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3808
hsasaki@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Tatsuno |
Organization
Keio University School of Medicine
Division name
Neurosurgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3808
Homepage URL
tatsunoy@a6.keio.jp
Sponsor or person
Institute
Department of Neurosurgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Keio University School of Medicine
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
慶應義塾大学病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、済生会宇都宮病院（栃木県）、東京歯科大学市川総合病院（千葉県）、藤田保健衛生大学附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | 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
| 2014 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020318
