Trial Outcomes & Findings for Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors (NCT NCT03194906)
NCT ID: NCT03194906
Last Updated: 2026-06-23
Results Overview
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.
COMPLETED
PHASE2
41 participants
Once, prior to enrollment
2026-06-23
Participant Flow
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.
41 patients were consent/screened for eligibility, with 7 not qualifying for the medication trial. The 34 randomized are dileneated below.
Participant milestones
| Measure |
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.
|
Placebo (Control)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Placebo (Control)
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.
|
|---|---|---|
|
Overall Study
Off Protocol
|
1
|
3
|
Baseline Characteristics
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors
Baseline characteristics by cohort
| Measure |
Memantine
n=16 Participants
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.
|
Placebo
n=14 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.29 years
STANDARD_DEVIATION 3.37 • n=20 Participants
|
11.51 years
STANDARD_DEVIATION 2.23 • n=20 Participants
|
11.93 years
STANDARD_DEVIATION 2.87 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · white
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · black
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Other
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Region of Enrollment
United States · Non-Hispanic
|
16 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Region of Enrollment
United States · Hispanic
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Memantine (Intervention) or Placebo (Control)
|
16 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Once, prior to enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=58 Participants
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.
|
Placebo (Control)
Placebo (Control)
|
|---|---|---|
|
Percent of Approached Participants Who Consent to Study Participation
|
70.69 percentage of participants
Interval 59.34 to 80.39
|
—
|
PRIMARY outcome
Timeframe: At completion of memantine/placebo therapy (12 weeks)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Percent of Participants Who Complete All 12 Weeks of Memantine/Placebo Therapy
|
93.75 percentage of participants
Interval 73.6 to 99.68
|
100 percentage of participants
Interval 80.74 to 100.0
|
PRIMARY outcome
Timeframe: At end of study (up to one year after study enrollment)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=30 Participants
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.
|
Placebo (Control)
Placebo (Control)
|
|---|---|---|
|
Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments
Total
|
100 percentage of participants
Interval 90.5 to 100.0
|
—
|
|
Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments
Memantine
|
100 percentage of participants
Interval 82.93 to 100.0
|
—
|
|
Percent of Participants Who Complete at Least 3 of 4 Cognitive Assessments
Placebo
|
100 percentage of participants
Interval 80.74 to 100.0
|
—
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
Identification RT Z score pre
|
0.86 Z score
Standard Deviation 1.27
|
.35 Z score
Standard Deviation 1.17
|
|
Change in Neurobehavioral Outcome
Identification RT Z score post
|
.56 Z score
Standard Deviation 1.04
|
.52 Z score
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at end of radiation therapy (6 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total pre
|
80.73 units on a scale
Standard Deviation 11.46
|
74.01 units on a scale
Standard Deviation 19.04
|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total post
|
79.17 units on a scale
Standard Deviation 18.59
|
71.43 units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
Identification RT Z score pre
|
.86 Z score
Standard Deviation 1.27
|
.4 Z score
Standard Deviation 1.2
|
|
Change in Neurobehavioral Outcome
Identification RT Z score post
|
.81 Z score
Standard Deviation 1.08
|
1.05 Z score
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at end of medication trial (12 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total pre
|
80.73 units on a scale
Standard Deviation 11.46
|
73.62 units on a scale
Standard Deviation 19.27
|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total post
|
80.9 units on a scale
Standard Deviation 14.77
|
60.79 units on a scale
Standard Deviation 27.49
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at follow-up (up to 1 year later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
Identification RT Z score pre
|
.81 Z score
Standard Deviation 1.29
|
.36 Z score
Standard Deviation 1.21
|
|
Change in Neurobehavioral Outcome
Identification RT Z score post
|
1.18 Z score
Standard Deviation 1.1
|
1.16 Z score
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At baseline (prior to start of therapy) compared at follow-up (up to 1 year later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total pre
|
79.36 units on a scale
Standard Deviation 11.18
|
74.04 units on a scale
Standard Deviation 19.59
|
|
Change in Neurobehavioral Outcome
PedsQL MDFS Total post
|
75.96 units on a scale
Standard Deviation 16.02
|
70.02 units on a scale
Standard Deviation 16.43
|
SECONDARY outcome
Timeframe: From start of memantine/placebo therapy through end of therapy (up to 12 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Memantine (Intervention) or Placebo (Control)
n=16 Participants
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.
|
Placebo (Control)
n=14 Participants
Placebo (Control)
|
|---|---|---|
|
Frequency of Memantine or Placebo Side Effects (All Groups)
|
14 Participants
|
14 Participants
|
Adverse Events
Pre-medication Baseline Memantine
Pre-medication Baseline Placebo
Week 1 - 12 Memantine
Week 1 - 12 Placebo
Serious adverse events
| Measure |
Pre-medication Baseline Memantine
n=16 participants at risk
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.
|
Pre-medication Baseline Placebo
n=14 participants at risk
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.
|
Week 1 - 12 Memantine
n=16 participants at risk
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.
|
Week 1 - 12 Placebo
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
7.1%
1/14 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
Other adverse events
| Measure |
Pre-medication Baseline Memantine
n=16 participants at risk
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.
|
Pre-medication Baseline Placebo
n=14 participants at risk
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.
|
Week 1 - 12 Memantine
n=16 participants at risk
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.
|
Week 1 - 12 Placebo
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
12.5%
2/16 • Number of events 3 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
14.3%
2/14 • Number of events 3 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Diarrhea
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
7.1%
1/14 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
6.2%
1/16 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
21.4%
3/14 • Number of events 9 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Dizziness
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
14.3%
2/14 • Number of events 5 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Headache
|
6.2%
1/16 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
14.3%
2/14 • Number of events 2 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
12.5%
2/16 • Number of events 4 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
28.6%
4/14 • Number of events 15 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Nausea
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Psychiatric
|
6.2%
1/16 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
7.1%
1/14 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
12.5%
2/16 • Number of events 2 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
35.7%
5/14 • Number of events 10 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
|
General disorders
Skin
|
0.00%
0/16 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
7.1%
1/14 • Number of events 1 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
12.5%
2/16 • Number of events 2 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
0.00%
0/14 • Acute adverse events were collected from baseline (pre-medication phase up to one week) and Weeks 1 to 12 (memantine or placebo).
|
Additional Information
Heather Conklin, PhD
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place