Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21CA218625 | U.S. NIH Grant/Contract | View source | |
| NCI-2017-01279 | Registry Identifier | NCI Clinical Trial Registration Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Children with brain tumors who have had radiation therapy are at risk for problems with attention, memory, and problem solving. Such problems may cause difficulty in school and daily life. Memantine, the drug being used for this study, is not yet approved for use in children by the U.S. Food and Drug Administration. However, studies have shown some improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder, and autism. Scientists have also used this medication for adult cancer patients receiving radiation therapy with results showing less cognitive declines over time compared to patients taking a placebo (inactive pill). These studies have also shown few side effects.
This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
Participants will be randomized to take part in one of two groups:
Participants will undergo the same evaluations and monitoring throughout the medication phase. Assessments will be done at baseline prior to study start, with follow-up assessments at 6 weeks (end of radiation therapy), and 12 weeks (end of study medication). Psychological testing to measure attention, working memory, problem solving, intelligence and academics will be done for each participant. Caregivers will also complete questionnaires about attention, problem solving, mood and interpersonal interactions. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history.
At the time points noted above, blood work, vital signs and echocardiograms will be obtained, and the study neurologist will examine the participant to monitor side effects and neurological functioning. A study nurse will contact the participant once per week during the 12 weeks of medication administration to identify possible medication-related side effects and to check on rate of compliance with taking the medication. A remote app will be installed on the participant's home computer or cell phone to help remind them to take the medication and track success. At one year post medication, psychological and neurological examinations will be repeated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Active Comparator | Beginning at least two weeks prior to radiation therapy, participants receive memantine. Treatment continues for 12 weeks with periodic cognitive assessments and lab work. |
|
| Placebo | Placebo Comparator | Beginning at least two weeks prior to radiation therapy, participants receive a placebo. Treatment and assessment are identical to the memantine group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Medication dosing will be overseen by one of the study neurologists, with step-wise dose reductions (5 mg intervals) allowable in the case of side effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Approached Participants Who Consent to Study Participation | The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 60%. The rate will be evaluated for the group as a whole. | Once, prior to enrollment |
| Percent of Participants Who Complete All 12 Weeks of Memantine/Placebo Therapy | The rates of medication adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 80%. The rate will be evaluated for the group as a whole as well as separately for the memantine intervention and placebo-control groups. | At completion of memantine/placebo therapy (12 weeks) |
| Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments | The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the memantine intervention and placebo-control groups. | At end of study (up to one year after study enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 6 weeks (end of radiation therapy) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heather M. Conklin, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
41 patients were consent/screened for eligibility, with 7 not qualifying for the medication trial. The 34 randomized are dileneated below.
From 11/1/17 to 6/22/22,103 potential patients were identified; 45 found ineligible upon review/physician consult. Seventeen families declined participation and 41 patients were consented/screened. There were 7 screen failures (eg, high liver enzymes, abnormal EKG, seizures). Thirty-four patients were randomized, 4 withdrew from study after randomization (pill swallowing, rash, preexisting cardiac issue, initiated new stimulant). Results are reported for 30 patients completing the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Memantine (Intervention) | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. |
| FG001 | Placebo (Control) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2021 |
Not provided
Not provided
Randomized, double-blind, placebo-controlled trial design.
Not provided
Not provided
Not provided
|
| Placebo | Other | A placebo that appears exactly like the study drug, memantine, will be given in a manner identical to the study drug. |
|
|
| Cognitive Assessment | Other | Cognitive and neurologic examinations will be conducted to assess cognitive, social, quality of life, and neurological outcomes associated with memantine at baseline prior to medication start, 6 weeks (end of radiation therapy), 12 weeks (discontinuation of study medication or placebo), and one year post radiation therapy. |
|
|
| At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later) |
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 6 weeks (end of radiation therapy) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 6 weeks. | At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later) |
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 12 weeks (end of medication trial) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 12 weeks. | At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later) |
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 12 weeks (end of medication trial) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 12 weeks. | At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later) |
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at follow-up (up to 1 year) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance.. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 1 year. | At baseline (prior to start of therapy) compared at follow-up (up to 1 year later) |
| Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at follow-up (up to 1 year) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 1 year. | At baseline (prior to start of therapy) compared at follow-up (up to 1 year later) |
| Frequency of Memantine or Placebo Side Effects (All Groups) | The frequency and nature of memantine side effects as measured by the SAFTEE will be evaluated qualitatively by calculating the frequency of side effect reporting by severity rating at different time points in the medication trial and comparing these frequencies across the memantine intervention and placebo-control groups. The frequency of side effects will be compared between the intervention and placebo-control groups using at t-test or other appropriate test, depending on the data distribution features of the compared outcome. | From start of memantine/placebo therapy through end of therapy (up to 12 weeks later) |
Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients with a diagnosis of an eligible localized low-grade glioma, craniopharyngioma, ependymoma, meningioma, or germ cell tumor who are between the ages of 6 years and 21 years will be recruited through the Radiation Oncology and Neuro-oncology clinics at St. Jude Children's Research Hospital (SJCRH).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Beginning at least two weeks prior to radiation therapy, participants receive memantine. Treatment continues for 12 weeks with periodic cognitive assessments and lab work. Memantine: Medication dosing will be overseen by one of the study neurologists, with step-wise dose reductions (5 mg intervals) allowable in the case of side effects. Cognitive Assessment: Cognitive and neurologic examinations will be conducted to assess cognitive, social, quality of life, and neurological outcomes associated with memantine at baseline prior to medication start, 6 weeks (end of radiation therapy), 12 weeks (discontinuation of study medication or placebo), and one year post radiation therapy. |
| BG001 | Placebo | Beginning at least two weeks prior to radiation therapy, participants receive a placebo. Treatment and assessment are identical to the memantine group. Placebo: A placebo that appears exactly like the study drug, memantine, will be given in a manner identical to the study drug. Cognitive Assessment: Cognitive and neurologic examinations will be conducted to assess cognitive, social, quality of life, and neurological outcomes associated with memantine at baseline prior to medication start, 6 weeks (end of radiation therapy), 12 weeks (discontinuation of study medication or placebo), and one year post radiation therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Memantine (Intervention) or Placebo (Control) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Approached Participants Who Consent to Study Participation | The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 60%. The rate will be evaluated for the group as a whole. | The number analyzed for this objective exceeds the total number of participants because the objective relates to participation rate. The study was offered to 58 patient families and 41 chose to consent for screening. So 41 participants started the study but 58 were analyzed to calculate acceptance rate. | Posted | Number | 90% Confidence Interval | percentage of participants | Once, prior to enrollment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent of Participants Who Complete All 12 Weeks of Memantine/Placebo Therapy | The rates of medication adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 80%. The rate will be evaluated for the group as a whole as well as separately for the memantine intervention and placebo-control groups. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Number | 90% Confidence Interval | percentage of participants | At completion of memantine/placebo therapy (12 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments | The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the memantine intervention and placebo-control groups. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Number | 90% Confidence Interval | percentage of participants | At end of study (up to one year after study enrollment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 6 weeks (end of radiation therapy) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | Z score | At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 6 weeks (end of radiation therapy) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 6 weeks. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | units on a scale | At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 12 weeks (end of medication trial) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 12 weeks. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | Z score | At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at 12 weeks (end of medication trial) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 12 weeks. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | units on a scale | At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at follow-up (up to 1 year) using paired difference divided by its estimated standard deviation. Cogstate Identification Reaction Time z-score (Identification RT Z) is an estimate of attention choice speed, with a mean of 0 and lower scores indicating faster (better) performance.. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 1 year. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | Z score | At baseline (prior to start of therapy) compared at follow-up (up to 1 year later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Neurobehavioral Outcome | The effect size (Cohen's d- the standardized difference between two means) of memantine on neurobehavioral outcomes (cognitive, social, quality of life, neurologic) will be estimated by comparing performance at baseline to performance at follow-up (up to 1 year) using paired difference divided by its estimated standard deviation. PedsQL Multidimensional Fatique Scale (MDFS) Total is an estimate of quality of life related to fatigue, ranging from 0 to 100, with higher scores indicating better outcomes. In addition, due to the missing data, mixed-effects models will be fitted to investigate the change of outcome from baseline to 1 year. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Mean | Standard Deviation | units on a scale | At baseline (prior to start of therapy) compared at follow-up (up to 1 year later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Memantine or Placebo Side Effects (All Groups) | The frequency and nature of memantine side effects as measured by the SAFTEE will be evaluated qualitatively by calculating the frequency of side effect reporting by severity rating at different time points in the medication trial and comparing these frequencies across the memantine intervention and placebo-control groups. The frequency of side effects will be compared between the intervention and placebo-control groups using at t-test or other appropriate test, depending on the data distribution features of the compared outcome. | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | Posted | Count of Participants | Participants | From start of memantine/placebo therapy through end of therapy (up to 12 weeks later) |
|
Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-medication Baseline Memantine | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | 0 | 16 | 0 | 16 | 8 | 16 |
| EG001 | Pre-medication Baseline Placebo | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | 0 | 14 | 0 | 14 | 12 | 14 |
| EG002 | Week 1 - 12 Memantine | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG003 | Week 1 - 12 Placebo | Medication will be initiated at least two weeks (± 7 days) prior to initiation of radiation therapy in order to achieve a therapeutic dose by radiation start. Medication will be prescribed for 12 weeks total. | 0 | 14 | 1 | 14 | 13 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment | Grade 3 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | General disorders | Systematic Assessment | Grade 1 |
| |
| Diarrhea | General disorders | Systematic Assessment | Grade 2 |
| |
| Dizziness | General disorders | Systematic Assessment | Grade 1 |
| |
| Dizziness | General disorders | Systematic Assessment | Grade 2 |
| |
| Fatigue | General disorders | Systematic Assessment | Grade 1 |
| |
| Fatigue | General disorders | Systematic Assessment | Grade 2 |
| |
| Headache | General disorders | Systematic Assessment | Grade 1 |
| |
| Headache | General disorders | Systematic Assessment | Grade 2 |
| |
| Nausea | General disorders | Systematic Assessment | Grade 1 |
| |
| Nausea | General disorders | Systematic Assessment | Grade 2 |
| |
| Psychiatric | General disorders | Systematic Assessment | Grade 1 |
| |
| Psychiatric | General disorders | Systematic Assessment | Grade 2 |
| |
| Skin | General disorders | Systematic Assessment | Grade 1 |
| |
| Skin | General disorders | Systematic Assessment | Grade 2 |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Conklin, PhD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
| May 7, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2021 | Feb 26, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003397 | Craniopharyngioma |
| D004806 | Ependymoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| D008508 | Medication Errors |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D019300 | Medical Errors |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| Male |
|
| black |
|
| Other |
|
| Hispanic |
|
|
|
|
|
|
|
|
The effect size (Cohen's d- the standardized difference between two means) of memantine and placebo on neurobehavioral outcomes was estimated at baseline and 6 weeks. Outcomes include PedsQL MDFS Total for social and quality of life. The effect size is defined as the pretest-posttest change in mean score divided by the standard deviation of change scores.
|
|
|
The effect size (Cohen's d- the standardized difference between two means) of memantine and placebo on neurobehavioral outcomes was estimated at baseline and 12 weeks. Outcomes include identification RT Z score for cognitive and neurologic. The effect size is defined as the pretest-posttest change in mean score divided by the standard deviation of change scores.
|
|
|
The effect size (Cohen's d- the standardized difference between two means) of memantine and placebo on neurobehavioral outcomes was estimated at baseline and 12 weeks. PedsQL MDFS Total for social and quality of life. The effect size is defined as the pretest-posttest change in mean score divided by the standard deviation of change scores.
|
|
|
The effect size (Cohen's d- the standardized difference between two means) of memantine and placebo on neurobehavioral outcomes was estimated at baseline and 1 year. Outcomes include identification RT Z score for cognitive and neurologic. The effect size is defined as the pretest-posttest change in mean score divided by the standard deviation of change scores.
|
|
|
|
|
|
| OG001 |
| Placebo (Control) |
The frequency and nature of memantine side effects as measured by the SAFTEE will be evaluated qualitatively by calculating the frequency of side effect reporting by severity rating at different time points in the medication trial and comparing these frequencies across the memantine intervention and placebo-control groups. The frequency of side effects will be compared between the intervention and placebo-control groups using at t-test or other appropriate test, depending on the data distribution features of the compared outcome. Frequency includes pretreatment baseline, within the placebo group, and all CTCAE grades of side effects. |
|
|