Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Sponsor

Mount Sinai Rehabilitation Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01399957

Collaborator

Brown University (Other), Acorda Therapeutics (Industry)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

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

Actual Enrollment :

52 participants

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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Change in 25ft walk time [Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks]
Change in 6 minute walk distance [Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks]
Measure of endurance

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital	Hartford	Connecticut	United States	06112

Sponsors and Collaborators

Mount Sinai Rehabilitation Hospital
Brown University
Acorda Therapeutics

Investigators

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