NCT01975324

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Neuro-Ophthalmologic Associates, PC · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

Detailed description

The aim of this study is to determine whether dalfampridine can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment. The objective of this double masked crossover study is to determine whether visual function can be improved in numerous parameters. This includes high contrast visual acuity, low contrast visual acuity, visual field, visual quality of life (VFQ-39), electrophysiology, multi focal electro retinography (mERG), visual evoked potential (VEP), and structure, spectral domain optical coherence tomography (OCT). Based on the promising results of the use of dalfampridine in Multiple Sclerosis (MS) and in stroke, we hypothesize that the patients with chronic stable deficits after nonarteritic ischemic optic neuropathy (NAION) will have improved visual function with the administration of dalfampridine.

Conditions

• Non Arteritic Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	dalfampridine	dalfampridine 10 mgs or placebo twice a day for two weeks, wash out period of two weeks, dalfampridine 10mgs or placebo twice a day for two weeks
DRUG	Placebo	placebo (sugar pill) twice a day for two weeks

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-11-04
• Last updated: 2016-01-25

Locations

1 site across 1 country: United States