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

Neuro-Ophthalmologic Associates, PC

Status and phase: Completed; Phase 4

Conditions: Non Arteritic Ischemic Optic Neuropathy

Treatments: Drug: Placebo; Drug: dalfampridine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01975324

Dalfampridine 13-265

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

dalfampridine (ampyra)

Experimental group

Description:

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

Treatment:

Drug: dalfampridine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo