Trial Outcomes & Findings for Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction? (NCT NCT01054599)
NCT ID: NCT01054599
Last Updated: 2017-07-11
Results Overview
Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
13 weeks
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Memantine
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Memantine
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
|---|---|---|
|
Overall Study
Dizziness due to phenytoin toxicity
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Spells/seizure-like episodes
|
1
|
1
|
|
Overall Study
Timing/scheduling difficulties
|
1
|
1
|
|
Overall Study
Visual impairment, WTAR <80
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction?
Baseline characteristics by cohort
| Measure |
Memantine
n=13 Participants
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
n=16 Participants
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Caucasian
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: The analysis includes subjects who completed both sessions 1 (baseline) and 2 (post-treatment/placebo). One subject in the memantine group completed both sessions, but the data were excluded from analysis due to seizures occurring during testing sessions 1 and 2, yielding n=8 in the memantine group.
Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units.
Outcome measures
| Measure |
Memantine
n=8 Participants
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
n=9 Participants
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
|---|---|---|
|
The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.
7-24 Spatial Recall Tests Learning Change Score
|
1.00 scores on a scale
Standard Deviation 2.00
|
1.78 scores on a scale
Standard Deviation 4.99
|
|
The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.
SRT Continuous Long-Term Retrieval Change Score
|
4.38 scores on a scale
Standard Deviation 7.6
|
8.11 scores on a scale
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 weeksPopulation: This analysis included only those subjects who participated in the open label extension period.
SRT-CLTR (range 0-72; higher scores indicate better memory), and 7-24 Spatial Memory Test (range 0-35; scores are summed across the 5 learning trials, with higher scores indicating better memory) scores will be assessed across the first (baseline) and third (post-open label memantine) testing sessions. These measures are considered to be scores on a scale, rather than standard units. The hypothesis was that subjects randomized to memantine would demonstrate sustained improvement from baseline, while the placebo group would demonstrate improvements after taking open label memantine (compared to baseline).
Outcome measures
| Measure |
Memantine
n=3 Participants
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
n=7 Participants
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
|---|---|---|
|
A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.
SRT CLTR Baseline
|
32.67 scores on a scale
Standard Deviation 14.01
|
22.71 scores on a scale
Standard Deviation 9.09
|
|
A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.
SRT CLTR Post-Open Label
|
40.33 scores on a scale
Standard Deviation 16.77
|
40.29 scores on a scale
Standard Deviation 18.81
|
|
A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.
7-24 Total Learning Baseline
|
30.33 scores on a scale
Standard Deviation 4.04
|
28.14 scores on a scale
Standard Deviation 5.67
|
|
A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.
7-24 Total Learning Post-Open Label
|
31.67 scores on a scale
Standard Deviation 4.93
|
32.43 scores on a scale
Standard Deviation 2.94
|
Adverse Events
Memantine
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Memantine
n=13 participants at risk
Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.
|
Sugar Pill
n=16 participants at risk
Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.
Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study
|
|---|---|---|
|
Nervous system disorders
Dizziness (due to phenytoin toxicity)
|
7.7%
1/13 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Increase/recurrence of seizure-like episodes
|
7.7%
1/13 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Generalized convulsion/seizure
|
0.00%
0/13
|
6.2%
1/16 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Beth Leeman-Markowski, MD
VA New York Harbor Healthcare System, NYU
Phone: 212-686-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place