Memantine RCT

JRCT ID: jRCTs071190010

Registered date:05/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant glioma classified as Grade3-4 by WHO classification 2016
• Date of first enrollment: 11/06/2018
• Target sample size: 29
• Study type: Interventional

Intervention(s)

1)Arm A: Patients randomly selected group have placebo tablets during radiotherapy
2)Arm B:Patients have 5mg of memantine during radiotherapy.
3)Arm C: 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.

Outcome(s)

Primary Outcome

Hippocampal function including recognition test
Higher brain function including excusive function

Secondary Outcome

Overall survival, Progression free survival
Hippocampal neurogenesis, Microstructure of white matter fiber, Quality of Life

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with malignant glioma who are classified as Grade3 to 4 of WHO classification 2016 using neuroradiological and histopathological diagnostic methods and undergo hyperbaric oxygen therapy and irradiation therapy.

Exclude criteria

1. Patients with hypersensitivity to the study drug.
2. Patients with impaired renal function.
3. Patients with factors that raise urine pH (tubular acidosis, severe urinary tract infection etc.).
4. Patients with advanced liver function disorder.(1. Increase in T-Bil, AST, ALT, ALP, gamma-GTP of CTACAE v4.0 grade2 or more, 2. Accompanied by abnormality of coagulation factor, 3. Suspected diseases of hepatobiliary system etc.).
5. Pregnant women, lactating women or ladies who may be pregnant.
6. Patients who require continued administration of drugs that may interact with the study drug (Dopamine agonist, hydrochlorothiazide, drug excreted by renal tubule secretion, drug causing urinary alkalization, drug having NMDA receptor antagonism).
7. Patients judged inappropriate as subjects of this study by research doctors.

Related Information

• Primary Sponsor: Ishiuchi Shogo
• Secondary ID(s): UMIN000018130