Ampyra for Optic Neuritis in MS
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis|
- Efficacy of Dalfampridine on visual function (contrast sensitivity). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- Dalfampridine reduce visual evoked potential P100 latency. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Dalfampridine treatment will result in an improvement quality of life.
|Study Start Date:||May 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Group A: Dalfampridine/Placebo||
Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
|Active Comparator: Group B: Placebo/Dalfampridine||
Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01337986
|United States, Missouri|
|Washington University (John L. Trotter MS Center)|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Robert T Naismith, MD||Washington University School of Medicine|