Clinical Trial: Ampyra for Optic Neuritis in MS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis

Brief Summary: Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery after optic neuritis from MS, will result in symptomatic improvement in visual function. The study will consist of one screening/baseline visit, one visit during treatment with active drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned to receive study medication or placebo for the first three weeks, followed by a two week wash-out, and then treatment reallocation for the latter three weeks.

Detailed Summary:

Optic neuritis (ON) is the presenting feature of multiple sclerosis (MS) in 15% of cases, and occurs over the disease course in 50% of patients.1-3 Vision remains a major concern for MS patients, as visual dysfunction leads to lower quality of life.4-6 Despite the high prevalence of ON in MS, treatment and management options remain limited. Although intravenous glucocorticoids are employed to aid recovery of an acute episode of ON, no convincing evidence supports their efficacy in altering the degree of long-term recovery.7 Although some individuals with ON can have a dramatic recovery from blindness, ON often impairs visual function permanently. In the Optic Neuritis Treatment Trial, 63% reported that vision had not returned to normal after 6 months, and 20% had vision worse than 20/20 after 5 years of follow-up.8, 9 Visual impairment creates difficulties at home and work, leading to decreased independence and impaired mobility within the community. Visual dysfunction in combination with MS impairments within cerebellar and proprioceptive systems can be particularly disabling.

Optic neuritis classically impairs one's ability to read print or a computer screen, to drive in bright or low light, and to appreciate colors and contrasts. Unfortunately, when optic neuritis results in lasting impairment, there are no pharmacologic therapies to restore vision. Low vision specialists may provide magnifying glasses, brighter lights, and advice to optimize the position of objects at home and in the workplace. Better treatment options are needed to improve visual function.

Ampyra (dalfampridine) is a potassium-channel antagonist, with a mechanism-of-action to improve nerve conduction in demyelinated axons, resulting in an electrophysiologic and clinical benefit.10-22 Demyelinated axons within the anterior visual pathway would be a pri
Sponsor: Washington University School of Medicine

Current Primary Outcome: Efficacy of Dalfampridine on visual function (contrast sensitivity). [ Time Frame: 8 weeks ]

Dalfampridine treatment will improve visual function, measured by the 5% ETDRS contrast sensitivity chart, in subjects with long-term visual impairment secondary to optic neuritis from MS.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dalfampridine reduce visual evoked potential P100 latency. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will reduce visual evoked potential P100 latency following remote optic neuritis.
  • Dalfampridine improvement in other vision testing (acuity, color, and fields). [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement in visual fields, high contrast visual acuity, and color vision.
  • Dalfampridine affect on quality of life. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement quality of life.


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: April 13, 2011
Date Started: May 2011
Date Completion:
Last Updated: February 14, 2014
Last Verified: February 2014