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Non Arteritic Ischemic Optic NeuropathyPhase 4AmpyraNCT01975324

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

A Phase 4 study testing dalfampridine in people with Non Arteritic Ischemic Optic Neuropathy, run by Neuro-Ophthalmologic Associates, PC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Non Arteritic Ischemic Optic Neuropathy
What is being tested?
dalfampridine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2013to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Neuro-Ophthalmologic Associates, PC

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

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

Read the 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.

Being tested
dalfampridine, Placebo
Keywords
Ampyra, NAION, Dalfampridine
Medical subject headings
Optic Neuropathy, Ischemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dalfampridineDrug

    Also called Ampyra

    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

  • PlaceboDrug

    Also called Sugar pill

    placebo (sugar pill) twice a day for two weeks

Study groups in NCT01975324
Study groupRoleWhat they receive
dalfampridine (ampyra)ExperimentalDalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks
Receives: Drug: dalfampridine
PlaceboPlacebo comparatorplacebo (sugar Pill) twice a day (b.i.d.)for two weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improve visual function

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975324
Sponsor's protocol ID
Dalfampridine 13-265
Acronym
Ampyra
Status last verified
Oct 2015
First submitted
26 Jul 2013
Last updated
25 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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. doi: 10.1016/s0002-9394(02)01639-2.

    PubMed 12208242

  • 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.

    PubMed 9620811

  • 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.

    PubMed 19430274

  • 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.

    PubMed 2317014

  • 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.

    PubMed 6631441

  • 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.

    PubMed 2435223

  • 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.

    PubMed 1324180

  • 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.

    PubMed 8208399

  • 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.

    PubMed 1891078

  • 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.

    PubMed 7980110

  • 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.

    PubMed 16415675

  • 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.

    PubMed 19249634

  • 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.

    PubMed 20976768

  • 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.

    PubMed 16269640

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dalfampridine in people with Non Arteritic Ischemic Optic Neuropathy, run by Neuro-Ophthalmologic Associates, PC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improve visual function (time frame: two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01975324, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.

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