Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in 25ft walk time
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed clinical diagnosis of MS by McDonald criteria
- •Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
- •Receive MS care at the Mandell MS center
- •Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
- •18 years of age or older
Exclusion Criteria
- •Already began to take drug prior to baseline research visit
- •Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
- •Unwilling or unable to complete assessments
Outcomes
Primary Outcomes
Change in 25ft walk time
Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Change in 6 minute walk distance
Time Frame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Measure of endurance
Secondary Outcomes
- Change of Upper extremity dexterity with 9hole peg test(Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks)
Investigators
Jennifer Ruiz, DPT
Research Manager
Mount Sinai Rehabilitation Hospital