Trial Outcomes & Findings for Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury (NCT NCT00462228)
NCT ID: NCT00462228
Last Updated: 2017-01-23
Results Overview
HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally. The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index. These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo
Results posted on
2017-01-23
Participant Flow
Subjects were recruited by contacting patients of the principal investigator (PI) when they presented for regularly scheduled clinic appointments or by referrals from colleagues. The recruitment period was from was from July 2007 through December 2010.
Participant milestones
| Measure |
Overall Study
All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
|
|---|---|
|
Memantine or Placebo 12 Weeks
STARTED
|
11
|
|
Memantine or Placebo 12 Weeks
COMPLETED
|
11
|
|
Memantine or Placebo 12 Weeks
NOT COMPLETED
|
0
|
|
No Treatment (Washout) 4 Weeks
STARTED
|
11
|
|
No Treatment (Washout) 4 Weeks
COMPLETED
|
11
|
|
No Treatment (Washout) 4 Weeks
NOT COMPLETED
|
0
|
|
Placebo or Memantine 12 Weeks
STARTED
|
11
|
|
Placebo or Memantine 12 Weeks
COMPLETED
|
11
|
|
Placebo or Memantine 12 Weeks
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Overall Study
n=11 Participants
All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after beginning memantine or placeboPopulation: All subjects completing the study.
HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally. The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index. These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.
baseline score
|
20.91 units on a scale
Standard Deviation 6.2
|
19.09 units on a scale
Standard Deviation 3.7
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.
6 week score
|
19.09 units on a scale
Standard Deviation 3.7
|
19.45 units on a scale
Standard Deviation 4.2
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.
12 week score
|
19.73 units on a scale
Standard Deviation 5.8
|
19.00 units on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after beginning memantine or placeboPopulation: All subjects completing the study.
HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally. The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall raw score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index. These scores are for the delayed recall learning raw score. The HVLT-R delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.
baseline score
|
5.64 units on a scale
Standard Deviation 3.8
|
4.36 units on a scale
Standard Deviation 2.5
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.
6 week score
|
4.45 units on a scale
Standard Deviation 2.7
|
5.18 units on a scale
Standard Deviation 3.5
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.
12 week score
|
4.73 units on a scale
Standard Deviation 3.3
|
5.82 units on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks after beginning Namenda or placeboPopulation: All subjects who completed the study.
BVMT-R total recall score. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. The total recall score is the sum of the three learning trials. After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page. These scores are for the total recall raw score which ranges from 0-36 with 36 being the highest and best possible score.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.
baseline score
|
18.09 units on a scale
Standard Deviation 6.9
|
15.09 units on a scale
Standard Deviation 7.8
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.
6 week score
|
18.18 units on a scale
Standard Deviation 7.4
|
17.54 units on a scale
Standard Deviation 7.5
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.
12 week score
|
17.45 units on a scale
Standard Deviation 6.8
|
17.18 units on a scale
Standard Deviation 8
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after beginning memantine or placeboPopulation: All subjects completing the study.
BVMT-R Delayed recall. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page. These scores are for the delayed recall raw score which ranges from 0 to 12 with 12 being the highest and best possible score.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.
baseline score
|
6.64 units on a scale
Standard Deviation 3.6
|
6.18 units on a scale
Standard Deviation 3.4
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.
6 week score
|
7.09 units on a scale
Standard Deviation 3.8
|
6.27 units on a scale
Standard Deviation 3.4
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.
12 week score
|
7.18 units on a scale
Standard Deviation 3.0
|
7.63 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksTrail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker's task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part A. This is a timed test and the number of seconds to complete the task is recorded.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.
baseline score
|
49.5 seconds
Standard Deviation 21.7
|
43.5 seconds
Standard Deviation 13.8
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.
6 week score
|
48.1 seconds
Standard Deviation 21.4
|
41.5 seconds
Standard Deviation 13.6
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.
12 week score
|
40.5 seconds
Standard Deviation 14.9
|
38.5 seconds
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after beginning memantine or placeboPopulation: All subjects completing the study.
Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has the more difficult task of drawing a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.
baseline score
|
104.6 seconds
Standard Deviation 54
|
113.3 seconds
Standard Deviation 63
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.
6 week score
|
128.7 seconds
Standard Deviation 94
|
100.8 seconds
Standard Deviation 38
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.
12 week score
|
86.6 seconds
Standard Deviation 32
|
105.5 seconds
Standard Deviation 69
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All subjects completing the study.
SDMT Written Scores. SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT written scores.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.
baseline score
|
35.9 units on a scale
Standard Deviation 11.5
|
36.1 units on a scale
Standard Deviation 7.9
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.
6 week score
|
36.5 units on a scale
Standard Deviation 9.4
|
39.8 units on a scale
Standard Deviation 8.4
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.
12 week score
|
38.2 units on a scale
Standard Deviation 9.8
|
39.8 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks after beginning memantine or placeboPopulation: All subjects completing the study.
SDMT Oral Score: SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT oral scores.
Outcome measures
| Measure |
Memantine
n=11 Participants
All subject scores for memantine regardless of sequence in the crossover design.
|
Placebo
n=11 Participants
All subject scores for placebo regardless of sequence in the crossover design.
|
|---|---|---|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.
baseline score
|
41.1 units on a scale
Standard Deviation 12.1
|
41.3 units on a scale
Standard Deviation 9.4
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.
6 week score
|
42.0 units on a scale
Standard Deviation 10.3
|
44.1 units on a scale
Standard Deviation 6.3
|
|
Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.
12 week score
|
43.9 units on a scale
Standard Deviation 9.4
|
46.4 units on a scale
Standard Deviation 7.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Memantine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
No Treatment (Washout)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
|
Memantine
n=11 participants at risk
All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
|
No Treatment (Washout)
n=11 participants at risk
All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
allergic cough
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Bilateral calf pain
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Stomach cramps
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
27.3%
3/11 • Number of events 4 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
27.3%
3/11 • Number of events 3 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
18.2%
2/11 • Number of events 3 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Skin and subcutaneous tissue disorders
Left great toe nail removed
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Right inguinal strain
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
General disorders
Headache
|
18.2%
2/11 • Number of events 2 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
18.2%
2/11 • Number of events 2 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder strain
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
18.2%
2/11 • Number of events 2 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Nervous system disorders
Confusion
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Right sided musculoskeletal pain
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder muscle strain
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Musculoskeletal and connective tissue disorders
Left calf strain
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Renal and urinary disorders
Urinary urgency
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
General disorders
Fall
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Nervous system disorders
Nervousness
|
0.00%
0/1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
General disorders
Dry mouth
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 2 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
9.1%
1/11 • Number of events 2 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
|
Nervous system disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
0.00%
0/11 • For each subject, adverse event data was collected during 12 weeks of treatment with memantine, 12 weeks of treatment with placebo, and during 2 separate 3 to 4 week washout periods following the memantine and placebo treatment periods.
|
Additional Information
Dr. S. Jon Rupright
Department of Physical Medicine and Rehabilitation, University of Missouri
Phone: 573-882-3101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publications and Copyrights: INSTITUTE will be free to publish papers dealing with final results of research under this Agreement, 90 days after submitting such papers to FOREST for review providing that INSTITUTE gives due regard to FOREST's comments on the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER