Memantine Hydrochloride for Brain Tumor

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Brain Tumor+1 MoreMemantine Hydrochloride - Drug
Eligibility
4 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares memantine to usual treatment in treating patients with brain tumors. Memantine may improve cognitive function in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.

Eligible Conditions
  • Brain Tumor

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 0 Secondary · Reporting Duration: At 12 months post baseline

Month 12
Incidence of composite cognitive score decline
Verbal memory score: CMS
Verbal memory score: WMS-IV
Verbal score: CVLT-C
Verbal score: CVLT-II
Visual memory score: CMS
Working memory score: WAIS-IV
Working memory score: WISC-V
Month 60
Executive functioning score
Intelligence quotient score
Processing speed score
Verbal memory score
Verbal score
Visual learning score
Visual memory score
Working memory score
verbal memory score
Month 30
Cogstate composite Z score: 30 months
At 36 months
Disease-free survival
Overall survival
Month 60
Cogstate composite Z score
Cogstate composite Z score: 60 months
At Baseline
Number of patients who consented to Biobanking
Month 12
Number of patients who consented to biobanking
Month 6
Estimate the difference in change of cogstate composite Z scores over time between 2 treatment arms
Month 7
Estimate the difference in change of Cogstate composite Z scores over time between 2 treatment arms
Up to 24 months
Progression-free survival
Up to 30 months
Molecular biomarkers analysis
Quantitative volumetric magnetic resonance imaging measurements of critical brain regions (hippocampus, frontal cortex)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Memantine 10mg
10%Headache
7%Light-headed/dizzy
This histogram enumerates side effects from a completed 2011 Phase 2 trial (NCT00585169) in the Memantine 10mg ARM group. Side effects include: Headache with 10%, Light-headed/dizzy with 7%.

Trial Design

2 Treatment Groups

Arm I (memantine hydrochloride)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

162 Total Participants · 2 Treatment Groups

Primary Treatment: Memantine Hydrochloride · Has Placebo Group · Phase 3

Arm I (memantine hydrochloride)Experimental Group · 2 Interventions: Memantine Hydrochloride, Cognitive Assessment · Intervention Types: Drug, Procedure
Arm II (placebo)PlaceboComparator Group · 2 Interventions: Placebo Administration, Cognitive Assessment · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
FDA approved
Cognitive Assessment
2011
Completed Phase 2
~1250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months post baseline

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
448 Previous Clinical Trials
236,348 Total Patients Enrolled
Nadia N LaackPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
39 Total Patients Enrolled

Eligibility Criteria

Age 4 - 17 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 6 to < 10 years old