Trial · NCT02391961

Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis

NCT02391961, Phase 2, Completed, VA Office of Research and Development; results first posted 2020-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis. Trials, record NCT02391961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02391961

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
NCT number: NCT02391961
Status: Completed
Phases: Phase 2
Enrollment: 23 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Multiple Sclerosis, Internuclear Ophthalmoplegia, Fatigue
Interventions: Dalfampridine, Placebo
First posted: 2015-03-18
Last updated: 2020-09-04
Results first posted: 2020-09-04

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	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.	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.
Primary	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 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.	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.
Secondary	Reading Acuity (RA)	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)
Secondary	Maximum Reading Speed (MRS)	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)
Secondary	Gait Assessment	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)
Secondary	National Eye Institute (NEI) Visual Function Questionnaire 25 (VFQ-25)	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.
Secondary	10-Item Neuro-Ophthalmic Supplement (NOS)	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	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.	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.	ratio	MEAN
PRIMARY	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 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.	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.	seconds	MEAN
SECONDARY	Reading Acuity (RA)	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.		logMAR for RA	MEAN
SECONDARY	Maximum Reading Speed (MRS)	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.		words per minute	MEAN
SECONDARY	Gait Assessment	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.		seconds	MEAN
SECONDARY	National Eye Institute (NEI) Visual Function Questionnaire 25 (VFQ-25)	VFQ25 was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks).		score on a scale	MEAN
SECONDARY	10-Item Neuro-Ophthalmic Supplement (NOS)	10-Item NOS was administered on day of visit 2 (after 4 weeks) and on day of visit 4 (after 10 weeks).		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	Dalfampridine	average pulse size ratio baseline	1.914	Standard Deviation 0.454	ratio
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	Placebo	average pulse size ratio baseline	1.937	Standard Deviation 0.553	ratio
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	Dalfampridine	average pulse size ratio after 3 hours	1.805	Standard Deviation 0.451	ratio
Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity.	Placebo	average pulse size ratio after 3 hours	1.898	Standard Deviation 0.508	ratio
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.	Dalfampridine	Average PTD at baseline	0.007	Standard Deviation 0.005	seconds
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.	Placebo	Average PTD at baseline	0.007	Standard Deviation 0.005	seconds
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.	Dalfampridine	Average PTD after 3 hours	0.008	Standard Deviation 0.004	seconds
Pulse Time Delay (PTD): Time Difference Between Onset of the Saccade in the Adducting Eye and Onset of the Saccade in the Abducting Eye.	Placebo	Average PTD after 3 hours	0.008	Standard Deviation 0.004	seconds
Reading Acuity (RA)	Dalfampridine	RA at baseline	0.111	Standard Deviation 0.117	logMAR for RA
Reading Acuity (RA)	Placebo	RA at baseline	0.108	Standard Deviation 0.138	logMAR for RA

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (4 Weeks)	STARTED	Dalfampridine, Then Placebo	10
First Intervention (4 Weeks)	STARTED	Placebo, Then Dalfampridine	9
First Intervention (4 Weeks)	COMPLETED	Dalfampridine, Then Placebo	8
First Intervention (4 Weeks)	COMPLETED	Placebo, Then Dalfampridine	9
First Intervention (4 Weeks)	NOT COMPLETED	Dalfampridine, Then Placebo	2
First Intervention (4 Weeks)	NOT COMPLETED	Placebo, Then Dalfampridine	0
Washout (2 Weeks)	STARTED	Dalfampridine, Then Placebo	8
Washout (2 Weeks)	STARTED	Placebo, Then Dalfampridine	9
Washout (2 Weeks)	COMPLETED	Dalfampridine, Then Placebo	7
Washout (2 Weeks)	COMPLETED	Placebo, Then Dalfampridine	8

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	known mild side effect of medication	Gastrointestinal disorders	Dalfampridine	1	17	1
other	known mild side effect of medication	Gastrointestinal disorders	Placebo	0	15	0
other	known side effect of medication	Nervous system disorders	Dalfampridine	1	17	1
other	known side effect of medication	Nervous system disorders	Placebo	0	15	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalfampridine	0	17
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Dalfampridine	2	17
Total, other adverse events	Placebo	0	15
Total, serious adverse events	Dalfampridine	0	17
Total, serious adverse events	Placebo	0	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29467711	BACKGROUND

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
IK2RX001180	Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis	SERRA, ALESSANDRO	LOUIS STOKES CLEVELAND VA MEDICAL CENTER	Veterans Affairs	2015 to 2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dalfampridine vs Placebo: deaths from any cause	Trial comparisons
Dalfampridine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02391961

GET https://conductscience.org/api/trials/v1/NCT02391961/results?page=2

API reference For AI assistants