Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01399957
• Lead Sponsor: Mount Sinai Rehabilitation Hospital

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Primary Completion: 2014-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital; 🇺🇸 Hartford, Connecticut, United States