UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026095 |
|---|---|
| Receipt number | R000029987 |
| Scientific Title | Evaluation of efficacy and safety of perampanel in post-operative glioma patients with epilepsy |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2024/02/25 09:14:43 |
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Basic information
Public title
Evaluation of efficacy and safety of perampanel in post-operative glioma patients with epilepsy
Acronym
Evaluation of efficacy and safety of perampanel in post-operative glioma patients with epilepsy
Scientific Title
Evaluation of efficacy and safety of perampanel in post-operative glioma patients with epilepsy
Scientific Title:Acronym
Evaluation of efficacy and safety of perampanel in post-operative glioma patients with epilepsy
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of efficacy and safety of perampanel in post-operative glioma patients with epilepsy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seizure free rate (Time Frame: 12 months after treatment)
Key secondary outcomes
PFS and OS of glioma patients
Base
Study type
Interventional
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
add 8 mg of PER on the patients treated with 1000mg of LEV for 1 year
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)age of 20/<= and <=75
2)no neoplasm detected by MRI on
optic nerve or pituitary
3)no multiple region or dissemination of the glioma on MRI
4)glioma confirmed by pathological examination on surgery
5)no past-history of chemotherapy or radiotherapy for other malignant disease
6)obtained the consent in writing from the patient
Key exclusion criteria
1)patients with contraindication of perampanel or levetiracetam
2)inadequate patient judged by the investigator
3)pregnant woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Izumoto |
Organization
Kindai University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
377-2 Ohno-Higashi Osaka-Sayama Osaka
TEL
072-366-0221
sizumoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Izumoto |
Organization
Kindai University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
377-2 Ohno-Higashi Osaka-Sayama Osaka
TEL
072-366-0221
Homepage URL
http://www.med.kindai.ac.jp/nouge/index.html
sizumoto@med.kindai.ac.jp
Sponsor or person
Institute
Kindai 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
近畿大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029987
