CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Dalfampridine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02391961
NCT02391961Phase 2Completed

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

VA Office of Research and Development·interventional·Posted Mar 18, 2015·Updated Sep 4, 2020

In Brief

A Phase 2 clinical trial evaluating Dalfampridine and Placebo for Multiple Sclerosis and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartApr 1, 2015
Primary CompletionJan 31, 2019
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.3 years ago

Interventions

Dalfampridinedrug

10-week randomized, placebo controlled, double-blind, crossover trial, which includes a period of wash out of two weeks between treatment with dalfampridine and placebo.

Placebodrug

10-week randomized, placebo controlled, double-blind, crossover trial, which includes a period of wash out of two weeks between treatment with dalfampridine and placebo.