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Clinical Trials/NCT01399957
NCT01399957CompletedNot Applicable

Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes

Mount Sinai Rehabilitation Hospital1 site in 1 country52 target enrollmentStarted: August 2010Last updated:
Conditions

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

Sponsor
Mount Sinai Rehabilitation Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Ruiz, DPT

Research Manager

Mount Sinai Rehabilitation Hospital

Study Sites (1)

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