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

Non Arteritic Ischemic Optic Neuropathy Clinical Trial

— Ampyra  

Official title:

Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975324
• Other study ID #: Dalfampridine 13-265
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2013
• Last updated: January 22, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Neuro-Ophthalmologic Associates, PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Non Arteritic Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

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
• Placebo
placebo (sugar pill) twice a day for two weeks

Locations

Country	Name	City	State
United States	Neuro-Ophthalmologic Associates, PC	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Neuro-Ophthalmologic Associates, PC	Acorda Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve visual function		two weeks