Ampyra for Optic Neuritis in MS
|ClinicalTrials.gov Identifier: NCT01337986|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Optic Neuritis||Drug: Dalfampridine/Placebo Drug: Placebo/Dalfampridine||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis|
|Study Start Date :||May 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
U.S. FDA Resources
|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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|