Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01399957

Enrollment

Registered

2011-07-22

Start date

2010-08-31

Completion date

2015-09-30

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Dalfampridine-ER, Walking speed

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United States

Outcome results