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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017531
Receipt No. 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

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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
Email 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
Email tatsunoy@a6.keio.jp

Sponsor
Institute Department of Neurosurgery, Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020318

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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