NCT01975324

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

July 26, 2013

Last Update Submit

January 22, 2016

Conditions

Non Arteritic Ischemic Optic Neuropathy

Keywords

AmpyraNAIONDalfampridine

Outcome Measures

Primary Outcomes (1)

  • Improve visual function

    two weeks

Study Arms (2)

dalfampridine (ampyra)

EXPERIMENTAL

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

Drug: dalfampridine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

dalfampridineDRUG

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

Also known as: Ampyra
dalfampridine (ampyra)
PlaceboDRUG

placebo (sugar pill) twice a day for two weeks

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NAION 6 months prior to enrollment
  • visual acuity of 20/40 or worse

You may not qualify if:

  • Current use of Dalfampridine (Ampyra)
  • Pregnancy
  • History of seizures
  • Renal Failure
  • Not able to perform testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro-Ophthalmologic Associates, PC

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (14)

  • 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.

    PMID: 12208242BACKGROUND

  • 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.

    PMID: 9620811BACKGROUND

  • 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.

    PMID: 19430274BACKGROUND

  • 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.

    PMID: 2317014BACKGROUND

  • 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.

    PMID: 6631441BACKGROUND

  • 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.

    PMID: 2435223BACKGROUND

  • 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.

    PMID: 1324180BACKGROUND

  • 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.

    PMID: 8208399BACKGROUND

  • 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.

    PMID: 1891078BACKGROUND

  • 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.

    PMID: 7980110BACKGROUND

  • 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.

    PMID: 16415675BACKGROUND

  • 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.

    PMID: 19249634BACKGROUND

  • 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.

    PMID: 20976768BACKGROUND

  • 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.

    PMID: 16269640BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

4-AminopyridineSugars

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Study Officials

  • Mark L Moster, MD

    Neuro-Ophthalmologic Associates, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuro-Ophthalmologist

Study Record Dates

First Submitted

July 26, 2013

First Posted

November 4, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2015-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)