UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018130 |
|---|---|
| Receipt number | R000020999 |
| Scientific Title | Efficacy of memantine treatment for the prevention and restration to cognitive dysfunction in patients receiving radiochemotherapy combined with hyperbaric oxygenation |
| Date of disclosure of the study information | 2015/07/31 |
| Last modified on | 2020/07/03 10:24:22 |
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Basic information
Public title
Efficacy of memantine treatment for the prevention and restration to cognitive dysfunction in patients receiving radiochemotherapy combined with hyperbaric oxygenation
Acronym
Efficancy of memantine treatment in cognitive dysfunction of patients with malignant gliomas
Scientific Title
Efficacy of memantine treatment for the prevention and restration to cognitive dysfunction in patients receiving radiochemotherapy combined with hyperbaric oxygenation
Scientific Title:Acronym
Efficancy of memantine treatment in cognitive dysfunction of patients with malignant gliomas
Region
| Japan |
Condition
Condition
Patients with malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We consider the protective effects of memantine on cognitive dysfunction in patients receiving radiotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pattern separation ability
Executive function, processing speed, attention, visuo-spatial function
Key secondary outcomes
Overall survival
Progression free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients have 5mg of memantine during radiotherapy.
Interventions/Control_2
Patients have 20mg of memantine during radiotherapy. They begin to have 5mg of memantine in the first week.Then a dose is escalating 5mg per week.
Interventions/Control_3
Patients randomly selected group have placebo tablets during radiotherapy
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
The patient with malignant glioma (grade 3-4) receiving radiochemotherapy combined with hyperbaric oxygenation
Key exclusion criteria
1.Patient with hypersensitivity for memantine
2.Patients with renal dysfunction
3.Patients with having factor ascend urinary pH
4.Patients with hepatic insufficiency
5.Patients with pregnancy
6.Patients who need the continuous medication having drug interact with memantine
7.Patients who were judged by doctors as not being appropriate subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Ishiuchi |
Organization
Graduate school of medicine,
University of the Ryukyus
Division name
Department of neurosurgery
Zip code
903-0125
Address
207 Nishihara-cho, Okinawa, Japan
TEL
098-895-1171
ishogo@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Oshiro |
Organization
Graduate school of medicine,
Division name
Department of neurosurgery
Zip code
903-0125
Address
207 Nishihara-cho, Okinawa, Japan
TEL
098-895-1171
Homepage URL
h149440@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Department of neurosurgery, Graduate school of medicine, University of Ryukyus
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Clinical research center, Unversity of the Ryukyus
Address
207 Nishihara-cho, Okinawa, Japan
Tel
098-895-1509
dataman.cr.ryukyu@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 31 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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