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

Information source: Neuro-Ophthalmologic Associates, PC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Arteritic Ischemic Optic Neuropathy

Intervention: dalfampridine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Neuro-Ophthalmologic Associates, PC

Official(s) and/or principal investigator(s):
Mark L Moster, MD, Principal Investigator, Affiliation: Neuro-Ophthalmologic Associates, PC

Summary

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

Clinical Details

Official title: Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Improve visual function

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.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Neuro-Ophthalmologic Associates, PC, Philadelphia, Pennsylvania 19107, United States
Additional Information

Related publications:

Newman NJ, Scherer R, Langenberg P, Kelman S, Feldon S, Kaufman D, Dickersin K; Ischemic Optic Neuropathy Decompression Trial Research Group. The fellow eye in NAION: report from the ischemic optic neuropathy decompression trial follow-up study. Am J Ophthalmol. 2002 Sep;134(3):317-28.

The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials. 1998 Jun;19(3):276-96.

Bever CT Jr. 10 questions about 4-aminopyridine and the treatment of multiple sclerosis. Neurologist. 2009 May;15(3):161-2. doi: 10.1097/NRL.0b013e3181679be5.

Davis FA, Stefoski D, Rush J. Orally administered 4-aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol. 1990 Feb;27(2):186-92.

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.

Stefoski D, Davis FA, Faut M, Schauf CL. 4-Aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol. 1987 Jan;21(1):71-7.

van Diemen HA, van Dongen MM, Dammers JW, Polman CH. Increased visual impairment after exercise (Uhthoff's phenomenon) in multiple sclerosis: therapeutic possibilities. Eur Neurol. 1992;32(4):231-4.

Bever CT Jr, Young D, Anderson PA, Krumholz A, Conway K, Leslie J, Eddington N, Plaisance KI, Panitch HS, Dhib-Jalbut S, et al. The effects of 4-aminopyridine in multiple sclerosis patients: results of a randomized, placebo-controlled, double-blind, concentration-controlled, crossover trial. Neurology. 1994 Jun;44(6):1054-9.

Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8.

Polman CH, Bertelsmann FW, de Waal R, van Diemen HA, Uitdehaag BM, van Loenen AC, Koetsier JC. 4-Aminopyridine is superior to 3,4-diaminopyridine in the treatment of patients with multiple sclerosis. Arch Neurol. 1994 Nov;51(11):1136-9.

Strupp M, Brandt T. Pharmacological advances in the treatment of neuro-otological and eye movement disorders. Curr Opin Neurol. 2006 Feb;19(1):33-40. Review.

Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.

Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.

Ho PW, Reutens DC, Phan TG, Wright PM, Markus R, Indra I, Young D, Donnan GA. Is white matter involved in patients entered into typical trials of neuroprotection? Stroke. 2005 Dec;36(12):2742-4. Epub 2005 Nov 3.

Starting date: July 2013
Last updated: July 30, 2014

Page last updated: August 20, 2015

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