Clinical trial NCT01975324: A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Official title: Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Arteritic Ischemic Optic Neuropathy
Keywords: Ampyra
NAION
Dalfampridine
Lead sponsor: Neuro-Ophthalmologic Associates, PC
Sponsor class: OTHER
Collaborators: name: Acorda Therapeutics
First posted: 2013-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improve visual function
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Neuro-Ophthalmologic Associates, PC
state: Pennsylvania
Study officials:
affiliation: Neuro-Ophthalmologic Associates, PC
name: Mark L Moster, MD
role: PRINCIPAL_INVESTIGATOR
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