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

Summary

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

Timeline

Start

2013-07

Primary completion

2015-12

Completion

2015-12

Publications

• Background 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. doi: 10.1016/s0002-9394(02)01639-2.
• Background The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials. 1998 Jun;19(3):276-96. doi: 10.1016/s0197-2456(98)00003-8.
• Background 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. No abstract available.
• Background 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.
• Background 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.
• Background Stefoski D, Davis FA, Faut M, Schauf CL. 4-Aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol. 1987 Jan;21(1):71-7. doi: 10.1002/ana.410210113.
• Background 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. doi: 10.1159/000116830.
• Background 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. doi: 10.1212/wnl.44.6.1054.
• Background 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. doi: 10.1212/wnl.41.9.1344.
• Background 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. doi: 10.1001/archneur.1994.00540230074016.
• Background 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. doi: 10.1097/01.wco.0000196156.00481.e1.
• Background 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.
• Background 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.
• Background 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. doi: 10.1161/01.STR.0000189748.52500.a7. Epub 2005 Nov 3.

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Indications