Trial | NCT01975324  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.
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.
Study Started
Jul 31
2013
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Jan 25
2016
Estimate

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

  • Other names: Ampyra

Drug Placebo

placebo (sugar pill) twice a day for two weeks

  • Other names: Sugar pill

dalfampridine (ampyra) Experimental

Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks

Placebo Placebo Comparator

placebo (sugar Pill) twice a day (b.i.d.)for two weeks

Criteria 

Inclusion Criteria:

NAION 6 months prior to enrollment
visual acuity of 20/40 or worse

Exclusion Criteria:

Current use of Dalfampridine (Ampyra)

Pregnancy
History of seizures
Renal Failure
Not able to perform testing
No Results Posted