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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018130
Receipt No. 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

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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
Email 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
Email h149440@med.u-ryukyu.ac.jp

Sponsor
Institute Department of neurosurgery, Graduate school of medicine, University of Ryukyus
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020999

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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