A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND# 149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors

Overview

To determine the efficacy, as measured by the slope of change of the Cogstate composite Z score from baseline to 12 months, of oral memantine administered for a period of 6 months, when compared to placebo, in children ages 4-18 receiving cranial or craniospinal radiotherapy for primary central nervous system tumors.

Description

This study is a Phase 3, double-blind, randomized placebo-controlled clinical trial inc hildren receiving focal, cranial, or craniospinal RT for primary brain tumors to evaluate whether memantine protects against cognitive decline assessed at 12 months.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: brain tumor
  • Age: Between 4 Years - 18 Years
  • Gender: Male or Female

 

Age:
≥4 and <18 years at time of study entry

Weight:
Patients must weigh 15 kg or greater at time of study entry.

Diagnosis:
Newly diagnosed or recurrent primary brain tumors that have not received prior cranial radiotherapy.

Patient must be able to undergo Magnetic Resonance Imaging (MRI).

 

Updated on 30 Nov 2022 . Study ID: TX11470
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