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

Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01975324

Acronym

Ampyra

Enrollment

Registered

2013-11-04

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Arteritic Ischemic Optic Neuropathy

Keywords

Ampyra, NAION, Dalfampridine

Brief 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.

Interventions

DRUGdalfampridine

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

DRUGPlacebo

placebo (sugar pill) twice a day for two weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improve visual function	two weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026