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NCT02391961 · ClinicalTrials.gov registry record · Phase 2
Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT02391961: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT02391961 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02391961, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
Primary fatigue represents a major cause of disability in patients with multiple sclerosis (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but, unfortunately, little is known about its mechanisms. The investigators propose a characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly encountered in MS, as a simple model for primary motor fatigue. The investigators described worsening of ocular performance in MS patients with INO following visual tasks (ocular motor fatigue), which is likely due to decreased neural conduction along brain pathways injured by MS. This mechanism could represent a major component of MS-related primary motor fatigue. Relevant to Veterans' care, INO is a significant cause of visual disability, especially when complicated by ocular fatigue, and limits daily activities such as reading and driving. The investigators propose a medical treatment to improve ocular performance/fatigue in INO, which can reduce visual disability and improve quality of life in Veterans with MS.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Dalfampridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2019-03-31 |
| Phase | Phase 2 |
What the finished NCT02391961 record still lists
NCT02391961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02391961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02391961 about?
NCT02391961 is a clinical study titled "Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis". Primary fatigue represents a major cause of disability in patients with multiple sclerosis (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but, unfortunately, little is known about its mechanisms. The investigators propose a characteristic eye movement abnorm...
What is the current status of trial NCT02391961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2015-04-01. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT02391961?
The interventions under investigation include: Placebo (DRUG), Dalfampridine (DRUG).
Who is sponsoring clinical trial NCT02391961?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02391961's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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