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

January 22, 2016 updated by: Mark L. Moster, M.d., Neuro-Ophthalmologic Associates, PC

Dalfampridine Treatment for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Neuro-Ophthalmologic Associates, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: dalfampridine (ampyra)
Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks
Drug: dalfampridine
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_COMPARATOR: Placebo
placebo (sugar Pill) twice a day (b.i.d.)for two weeks
Drug: Placebo
placebo (sugar pill) twice a day for two weeks
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improve visual function
Time Frame: two weeks
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro-Ophthalmologic Associates, PC

Collaborators

Acorda Therapeutics

Investigators

  • Principal Investigator: Mark L Moster, MD, Neuro-Ophthalmologic Associates, PC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (ESTIMATE)

November 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dalfampridine 13-265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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