Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes|
- Change in 25ft walk time [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ] [ Designated as safety issue: Yes ]
- Change in 6 minute walk distance [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ] [ Designated as safety issue: Yes ]Measure of endurance
- Change of Upper extremity dexterity with 9hole peg test [ Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
15 mL of blood will be collected into an EDTA tube from participants at assessment appointments. Both serum and cells will be frozen and stored in a -80 degree freezer.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
pwMS prescribed dalfampridine-ER
Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months.
Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399957
|United States, Connecticut|
|Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital|
|Hartford, Connecticut, United States, 06112|
|Principal Investigator:||Albert Lo, M.D, Ph.D.||Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital|
|Principal Investigator:||Elizabeth Triche, Ph.D||Brown University|