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Completed

NCT Number: NCT01975324

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

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

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Key information

Conditions

Non Arteritic Ischemic Optic Neuropathy Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neuro-Ophthalmologic Associates, PC

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalfampridine

Drug

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

Placebo

Drug

placebo (sugar pill) twice a day for two weeks

Other names: Sugar pill

Primary outcomes

  1. Improve visual function

    Time frame: two weeks

Sponsors and collaborators

Lead sponsor

Neuro-Ophthalmologic Associates, PC

Other

Collaborators

  • Acorda Therapeutics

Registry information

Official study title

Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Acronym: Ampyra

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2013
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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