Trial Outcomes & Findings for Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis (NCT NCT02391961)
NCT ID: NCT02391961
Last Updated: 2020-09-04
Results Overview
For each saccade made by the subject, the ratio of the maximum velocity (deg/sec) of the eye moving away from the nose and of the eye moving towards the nose was calculated. Subjects' horizontal saccades were recorded for 10 minutes, and an average of PSR for all saccades recorded was taken.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Average PSR values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.
Results posted on
2020-09-04
Participant Flow
(4) subjects were enrolled, but did not pass initial screening procedures at study visit 1 and therefore were not assigned to a study group.
Participant milestones
| Measure |
Dalfampridine, Then Placebo
Participants were randomized to receive dalfampridine 10 mg tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive placebo tablet twice a day (matching dalfampridine 10 mg tablet) for 4 weeks (Second Intervention).
|
Placebo, Then Dalfampridine
Participants were randomized to receive placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg tablet twice a day for 4 weeks (Second Intervention).
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
10
|
9
|
|
First Intervention (4 Weeks)
COMPLETED
|
8
|
9
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Washout (2 Weeks)
STARTED
|
8
|
9
|
|
Washout (2 Weeks)
COMPLETED
|
7
|
8
|
|
Washout (2 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (4 Weeks)
STARTED
|
7
|
8
|
|
Second Intervention (4 Weeks)
COMPLETED
|
6
|
7
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dalfampridine, Then Placebo
Participants were randomized to receive dalfampridine 10 mg tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive placebo tablet twice a day (matching dalfampridine 10 mg tablet) for 4 weeks (Second Intervention).
|
Placebo, Then Dalfampridine
Participants were randomized to receive placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg tablet twice a day for 4 weeks (Second Intervention).
|
|---|---|---|
|
First Intervention (4 Weeks)
Adverse Event
|
2
|
0
|
|
Washout (2 Weeks)
Withdrawal by Subject
|
1
|
1
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Dalfampridine, Then Placebo
n=17 INO
Participants were randomized to receive dalfampridine 10 mg tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive placebo tablet twice a day (matching dalfampridine 10 mg tablet) for 4 weeks (Second Intervention).
|
Placebo, Then Dalfampridine
n=15 INO
Participants were randomized to receive placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg tablet twice a day for 4 weeks (Second Intervention).
|
Total
n=32 INO
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average PSR values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.Population: Some participants withdrew after visit 1, visit 2 or 3. (1) more participant was not included in the final analysis as missing a datapoint (baseline data at Visit 2). Thus, the number above (12) is the number of participants who completed the full protocol from visit 1 to visit 4.
For each saccade made by the subject, the ratio of the maximum velocity (deg/sec) of the eye moving away from the nose and of the eye moving towards the nose was calculated. Subjects' horizontal saccades were recorded for 10 minutes, and an average of PSR for all saccades recorded was taken.
Outcome measures
| Measure |
Dalfampridine
n=20 INO (internuclear ophthalmoparesis)
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=20 INO (internuclear ophthalmoparesis)
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.
average pulse size ratio baseline
|
1.914 ratio
Standard Deviation 0.454
|
1.937 ratio
Standard Deviation 0.553
|
|
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.
average pulse size ratio after 3 hours
|
1.805 ratio
Standard Deviation 0.451
|
1.898 ratio
Standard Deviation 0.508
|
PRIMARY outcome
Timeframe: Average PTD values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.Population: Some participants withdrew after visit 1, visit 2 or 3. (1) more participant was not included in the final analysis as missing a datapoint (baseline data at Visit 2). Thus, the number above (12) is the number of participants who completed the full protocol from visit 1 to visit 4.
For each saccade made by the subject, we calculated the difference (in sec) between the onset (based on a velocity threshold) of the movement in the adducting eye (the eye moving towards the nose) and the onset of the movement in the abducting eye (the eye moving away from the nose). Subjects' horizontal saccades were recorded for 10 minutes, and an average of PTD for all saccades recorded was taken.
Outcome measures
| Measure |
Dalfampridine
n=20 INO (internuclear ophthalmoparesis)
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=20 INO (internuclear ophthalmoparesis)
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.
Average PTD at baseline
|
0.007 seconds
Standard Deviation 0.005
|
0.007 seconds
Standard Deviation 0.005
|
|
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.
Average PTD after 3 hours
|
0.008 seconds
Standard Deviation 0.004
|
0.008 seconds
Standard Deviation 0.004
|
SECONDARY outcome
Timeframe: Average RA values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.MNREAD acuity charts for reading acuity (RA)
Outcome measures
| Measure |
Dalfampridine
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
Reading Acuity (RA)
RA at baseline
|
0.111 logMAR for RA
Standard Deviation 0.117
|
0.108 logMAR for RA
Standard Deviation 0.138
|
|
Reading Acuity (RA)
RA after 3 hours
|
0.088 logMAR for RA
Standard Deviation 0.121
|
0.086 logMAR for RA
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Average MRS values were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.MNREAD acuity charts for reading speed (maximum reading speed, MRS)
Outcome measures
| Measure |
Dalfampridine
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
Maximum Reading Speed (MRS)
MRS at baseline
|
156 words per minute
Standard Deviation 31
|
151.7 words per minute
Standard Deviation 20
|
|
Maximum Reading Speed (MRS)
MRS after 3 hours
|
158 words per minute
Standard Deviation 19
|
158.7 words per minute
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Measures were taken on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks), on each visit before (baseline) and three hours after taking the study pill.25-foot Walk Test (FWT)
Outcome measures
| Measure |
Dalfampridine
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
Gait Assessment
25 FWT baseline
|
8.986 seconds
Standard Deviation 4.957
|
9.113 seconds
Standard Deviation 4.639
|
|
Gait Assessment
25 FWT after 3 hours
|
8.567 seconds
Standard Deviation 5.352
|
9.184 seconds
Standard Deviation 5.400
|
SECONDARY outcome
Timeframe: VFQ25 was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks).We used a validated questionnaire to assess visual disability, the National Eye Institute (NEI) Visual Function Questionnaire 25. Min value 0; Max value 100; Higher scores mean a better outcome.
Outcome measures
| Measure |
Dalfampridine
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
National Eye Institute (NEI) Visual Function Questionnaire 25 (VFQ-25)
|
73.48 score on a scale
Standard Deviation 16.65
|
71.62 score on a scale
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: 10-Item NOS was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks).We used a validated questionnaire to assess visual disability, the 10-Item Neuro-Ophthalmic Supplement. Min value 0; Max value 100; Higher scores mean a better outcome.
Outcome measures
| Measure |
Dalfampridine
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on dalfampridine.
|
Placebo
n=12 Participants
Participants were randomized to receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (First Intervention) then, after a washout period of 2 weeks, did receive dalfampridine 10 mg or placebo tablet twice a day for 4 weeks (Second Intervention), according to the trial crossover design.
Here we report results from participants while on placebo.
|
|---|---|---|
|
10-Item Neuro-Ophthalmic Supplement (NOS)
|
64.9 score on a scale
Standard Deviation 24
|
64.3 score on a scale
Standard Deviation 25
|
Adverse Events
Dalfampridine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dalfampridine
n=17 participants at risk
Participants received dalfampridine 10 mg tablet twice a day for 4 weeks.
|
Placebo
n=15 participants at risk
Participants received placebo tablet (matching dalfampridine 10 mg tablet) twice a day for 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
known mild side effect of medication
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected for each subject during their participation time in the study from time of enrollment to study completion or withdrawal, an average of 10 weeks.
|
0.00%
0/15 • Adverse event data was collected for each subject during their participation time in the study from time of enrollment to study completion or withdrawal, an average of 10 weeks.
|
|
Nervous system disorders
known side effect of medication
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected for each subject during their participation time in the study from time of enrollment to study completion or withdrawal, an average of 10 weeks.
|
0.00%
0/15 • Adverse event data was collected for each subject during their participation time in the study from time of enrollment to study completion or withdrawal, an average of 10 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place