Trial Outcomes & Findings for Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus (NCT NCT00928954)
NCT ID: NCT00928954
Last Updated: 2016-07-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
After 2 weeks of therapy, for both drugs
Results posted on
2016-07-29
Participant Flow
Participant milestones
| Measure |
Gabapentin First and Then Memantine
Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.
|
Memantine First, Then Gabapentin
Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 2 weeks of therapy, for both drugsOutcome measures
| Measure |
Gabapentin
n=10 Participants
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
gabapentin: increasing to 1200 mg/day
|
Memantine
n=10 Participants
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
memantine: increasing to 40 mg/day
|
|---|---|---|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 1, Right Eye
|
0 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 1, Left Eye
|
0.2 logMAR
|
0.2 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 2, Right Eye
|
0.1 logMAR
|
0.2 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 2, Left Eye
|
0.2 logMAR
|
0 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 3, RIght Eye
|
-0.1 logMAR
|
-0.2 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 3, Left Eye
|
NA logMAR
Below level of detection
|
NA logMAR
Below level of detection
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Patricipant 4, RIght Eye
|
0.3 logMAR
|
-0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 4, Left Eye
|
0.1 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 5, Right Eye
|
0.1 logMAR
|
0.2 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 5, Left Eye
|
0 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 6, RIght Eye
|
0.4 logMAR
|
0 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 6, Left Eye
|
0.2 logMAR
|
0.2 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 7, Right Eye
|
-0.1 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 7, Left Eye
|
0.1 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 8, Right Eye
|
0.1 logMAR
|
0 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 8, Left Eye
|
0 logMAR
|
0.1 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Particpant 9, Right Eye
|
0 logMAR
|
0 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 9, Left Eye
|
0 logMAR
|
0 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 10, Right Eye
|
-0.1 logMAR
|
0.3 logMAR
|
|
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Participant 10. Left Eye
|
0.1 logMAR
|
0.2 logMAR
|
PRIMARY outcome
Timeframe: After 2 weeks of therapy, for both drugsMedian eye speed during attempted visual fixation by each eye
Outcome measures
| Measure |
Gabapentin
n=10 Participants
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
gabapentin: increasing to 1200 mg/day
|
Memantine
n=10 Participants
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
memantine: increasing to 40 mg/day
|
|---|---|---|
|
Percent Change in Median Eye Speed
Participant 4, Left Eye
|
-76.6 Percent change
|
11.4 Percent change
|
|
Percent Change in Median Eye Speed
Participant 5, Right Eye
|
-56.6 Percent change
|
-35.5 Percent change
|
|
Percent Change in Median Eye Speed
Participant 1, Right Eye
|
-59.1 Percent change
|
-21.5 Percent change
|
|
Percent Change in Median Eye Speed
Participant 1, Left Eye
|
-69.8 Percent change
|
-35.1 Percent change
|
|
Percent Change in Median Eye Speed
Participant 2, Right Eye
|
-19.9 Percent change
|
-26.0 Percent change
|
|
Percent Change in Median Eye Speed
Participant 2, Left Eye
|
-19.8 Percent change
|
-35.5 Percent change
|
|
Percent Change in Median Eye Speed
Participant 3, RIght Eye
|
-53.5 Percent change
|
-44.6 Percent change
|
|
Percent Change in Median Eye Speed
Participant 3, Left Eye
|
-41.3 Percent change
|
-40.2 Percent change
|
|
Percent Change in Median Eye Speed
Patricipant 4, RIght Eye
|
-72.8 Percent change
|
-8.6 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 5, Left Eye
|
-42.0 Percent change
|
-26.5 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 6, RIght Eye
|
-26.0 Percent change
|
-44.8 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 6, Left Eye
|
-25.9 Percent change
|
-29.5 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 7, Right Eye
|
49.5 Percent change
|
-29.0 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 7, Left Eye
|
26.5 Percent change
|
-24.1 Percent change
|
|
Percent Change in Median Eye Speed
Participant 8, Right Eye
|
-0.9 Percent change
|
-60.4 Percent change
|
|
Percent Change in Median Eye Speed
Participant 8, Left Eye
|
-0.7 Percent change
|
-24.8 Percent change
|
|
Percent Change in Median Eye Speed
Particpant 9, Right Eye
|
-39.5 Percent change
|
2.2 Percent change
|
|
Percent Change in Median Eye Speed
Participant 9, Left Eye
|
-44.1 Percent change
|
-19.4 Percent change
|
|
Percent Change in Median Eye Speed
Participant 10, Right Eye
|
159 Percent change
|
-80.6 Percent change
|
|
Percent Change in Median Eye Speed
Participant 10. Left Eye
|
104.4 Percent change
|
-79.3 Percent change
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Memantine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place