Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Mount Sinai Rehabilitation Hospital

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01399957

AL0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

52 participants in 1 patient group

pwMS prescribed dalfampridine-ER

Description:

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.