Trial intelligence / Profile preview

Dalfampridine for Visual Dysfunction and Motor Fatigue in MS

NCT02391961Phase 2

Key facts

Status: Completed
Start: Apr 2015
Primary completion: Jan 2019
Countries: 1
Sponsor: VA Office of Research & Development
Modality: Small Molecules

Drugs: dalfampridine
Conditions: multiple sclerosis (MS)internuclear ophthalmoplegia (INO)

Overview

Phase 2, randomised, double-blind trial in multiple sclerosis (MS) and internuclear ophthalmoplegia (INO) comparing Dalfampridine with Placebo (2 arms). Primary endpoints: Pulse Size Ratio and Pulse Time Delay. Started Apr 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Dalfampridine
Dalfampridine 10mg twice daily
Placebo
Matching placebo

Who it enrols

Patients with Multiple Sclerosis and mild to moderate internuclear ophthalmoparesis (INO). Excludes severe INO (exotropia), history of seizures, and moderate/severe renal failure.

Endpoints

Primary

Pulse Size Ratio3 hours post-dose
Pulse Time Delay3 hours post-dose

Secondary

Reading Acuity3 hours post-dose
Maximum Reading Speed3 hours post-dose
Gait Assessment3 hours post-dose
National Eye Institute Visual Function Questionnaire 2510 weeks
10-Item Neuro-Ophthalmic Supplement10 weeks

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