Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients



Status:Completed
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2010
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.

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
We found this trial at
1
site
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Hartford, Connecticut 06112
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mi
from
Hartford, CT
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