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

Phase 4

Completed

• Conditions: Non Arteritic Ischemic Optic Neuropathy
• Interventions: Drug: Placebo; Drug: dalfampridine

• Registration Number: NCT01975324
• Lead Sponsor: Neuro-Ophthalmologic Associates, PC

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Status Verified: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo (sugar Pill) twice a day (b.i.d.)for two weeks
dalfampridine (ampyra)	dalfampridine	Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks

Primary Outcome Measures

Name	Time	Method
Improve visual function	two weeks

Trial Locations

Locations (1)

Neuro-Ophthalmologic Associates, PC; 🇺🇸 Philadelphia, Pennsylvania, United States