A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor
NCT04939597 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2025-12-22
Summary
This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
Conditions
- Central Nervous System Carcinoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Cognitive Assessment
Complete cognitive testing
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- DRUG
-
Memantine Hydrochloride
Given PO
- DRUG
-
Placebo Administration
Given PO
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Nadia N Laack · Children's Oncology Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-10
- Primary Completion
- 2026-06-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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