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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975324
Recruitment Status : Completed
First Posted : November 3, 2013
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Mark L. Moster, M.d., 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.

Condition or disease Intervention/treatment Phase
Non Arteritic Ischemic Optic Neuropathy Drug: dalfampridine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Sugar pill




Primary Outcome Measures :
  1. Improve visual function [ Time Frame: two weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975324


Locations
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United States, Pennsylvania
Neuro-Ophthalmologic Associates, PC
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Neuro-Ophthalmologic Associates, PC
Acorda Therapeutics
Investigators
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Principal Investigator: Mark L Moster, MD Neuro-Ophthalmologic Associates, PC
Publications:

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Responsible Party: Mark L. Moster, M.d., Neuro-Ophthalmologist, Neuro-Ophthalmologic Associates, PC
ClinicalTrials.gov Identifier: NCT01975324    
Other Study ID Numbers: Dalfampridine 13-265
First Posted: November 3, 2013    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark L. Moster, M.d., Neuro-Ophthalmologic Associates, PC:
Ampyra
NAION
Dalfampridine
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuropathy, Ischemic
Ischemia
Pathologic Processes
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action