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A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 192 to confirmed 162 Study sites revised (138)v41 Show 1 more changeShow less
    • Study sites revised (138)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (138)v40 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv39
  4. Study sites revised (138)v38 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Sep 30, 2027 to Jun 30, 2026v37
Show 35 earlier versionsHide 35 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Eligibility criteria revised · Site details revised at 138 of 138 sites · Study title shortened, about 2 wordsv36 Show 3 more changesShow less
    • Eligibility criteria revised
    • Site details revised at 138 of 138 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 137 to 138v35
  3. Study sites: 135 to 137v34
  4. Study sites: 133 to 135v33
  5. Site details revised at 3 of 133 sitesv32
  6. Site details revised at 2 of 133 sitesv31
  7. Study sites: 130 to 133v30
  8. Start date: Nov 15, 2021 to May 10, 2022v29
  9. Site details revised at 8 of 130 sitesv28
  10. 2 versions Re-verified since Jan 16, 2024, no change to tracked fieldsv26-v27
  11. Primary endpoint revised Site details revised at 3 of 130 sitesv25 Show 1 more changeShow less
    • Site details revised at 3 of 130 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 2 of 130 sitesv24
  13. Study sites: 127 to 130 Start date: May 10, 2022 to Nov 15, 2021 · Interventions: Cognitive Assessment (Procedure), Memantine Hydrochloride (Drug), Placebo Administration (Drug) to Biospecimen Collection (Procedure), Cognitive Assessment (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride… · Eligibility criteria expanded, about 22 words · 2 morev23 Show 5 more changesShow less
    • Start date: May 10, 2022 to Nov 15, 2021
    • Interventions: Cognitive Assessment (Procedure), Memantine Hydrochloride (Drug), Placebo Administration (Drug) to Biospecimen Collection (Procedure), Cognitive Assessment (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride…
    • Eligibility criteria expanded, about 22 words
    • Study description expanded, about 40 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  14. Trial status: Active, Not Recruiting to Recruiting Site details revised at 127 of 127 sitesv22 Show 1 more changeShow less
    • Site details revised at 127 of 127 sites
  15. Site details revised at 1 of 127 sitesv21
  16. Trial status: Recruiting to Active, Not Recruiting Study sites: 123 to 127v20 Show 1 more changeShow less
    • Study sites: 123 to 127
  17. Start date: Nov 15, 2021 to May 10, 2022v19
  18. Study sites: 120 to 123v18
  19. Study sites: 118 to 120v17
  20. Enrollment target: 162 to 192 Site details revised at 1 of 118 sitesv16 Show 1 more changeShow less
    • Site details revised at 1 of 118 sites
  21. Re-verified, no change to tracked fieldsv15
  22. Primary endpoint revised Study sites: 116 to 118 · Study description revisedv14 Show 2 more changesShow less
    • Study sites: 116 to 118
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 109 to 116v13
  24. Study sites: 69 to 109v12
  25. Study sites: 55 to 69v11
  26. Study sites: 38 to 55v10
  27. Study sites: 33 to 38v9
  28. Study sites: 29 to 33v8
  29. Study sites: 28 to 29v7
  30. Study sites: 26 to 28 Primary and study completion dates: Jul 19, 2027 to Sep 30, 2027v6 Show 1 more changeShow less
    • Primary and study completion dates: Jul 19, 2027 to Sep 30, 2027
  31. Re-verified, no change to tracked fieldsv5
  32. Study sites: 15 to 26 Completion date: Jul 19, 2030 to Jul 19, 2027 · Collaborators shortened, about 4 wordsv4 Show 2 more changesShow less
    • Completion date: Jul 19, 2030 to Jul 19, 2027
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 1 to 15v3
  34. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 15, 2030 to Jul 19, 2027 · Primary endpoint revised · Study sites: 0 to 1 · 4 morev2 Show 7 more changesShow less
    • Primary completion date: Oct 15, 2030 to Jul 19, 2027
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Completion date: Oct 15, 2030 to Jul 19, 2030
    • Start date changed from estimate of Sep 1, 2021 to Nov 15, 2021
    • Eligibility criteria expanded, about 11 words
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04939597
Lead Sponsor Children's Oncology Group
Conditions Central Nervous System Carcinoma
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov