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

Primary Purpose

Non Arteritic Ischemic Optic Neuropathy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dalfampridine
Placebo
Sponsored by
Neuro-Ophthalmologic Associates, PC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Arteritic Ischemic Optic Neuropathy focused on measuring Ampyra, NAION, Dalfampridine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Neuro-Ophthalmologic Associates, PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dalfampridine (ampyra)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improve visual function

Secondary Outcome Measures

Full Information

First Posted
July 26, 2013
Last Updated
January 22, 2016
Sponsor
Neuro-Ophthalmologic Associates, PC
Collaborators
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01975324
Brief Title
A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Acronym
Ampyra
Official Title
Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuro-Ophthalmologic Associates, PC
Collaborators
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Arteritic Ischemic Optic Neuropathy
Keywords
Ampyra, NAION, Dalfampridine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dalfampridine (ampyra)
Arm Type
Experimental
Arm Description
Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo (sugar Pill) twice a day (b.i.d.)for two weeks
Intervention Type
Drug
Intervention Name(s)
dalfampridine
Other Intervention Name(s)
Ampyra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
placebo (sugar pill) twice a day for two weeks
Primary Outcome Measure Information:
Title
Improve visual function
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Moster, MD
Organizational Affiliation
Neuro-Ophthalmologic Associates, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro-Ophthalmologic Associates, PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12208242
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
2317014
Citation
Davis FA, Stefoski D, Rush J. Orally administered 4-aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol. 1990 Feb;27(2):186-92. doi: 10.1002/ana.410270215.
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PubMed Identifier
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Jones RE, Heron JR, Foster DH, Snelgar RS, Mason RJ. Effects of 4-aminopyridine in patients with multiple sclerosis. J Neurol Sci. 1983 Aug-Sep;60(3):353-62. doi: 10.1016/0022-510x(83)90145-4.
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PubMed Identifier
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Citation
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Citation
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Citation
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A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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