Clinical Trials Directory

Trials / Completed

CompletedNCT01444300

Dalfampridine for Imbalance in Multiple Sclerosis

Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
All
Age
20 Years – 59 Years
Healthy volunteers
Not accepted

Summary

Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.

Conditions

Interventions

TypeNameDescription
DRUGDalfampridine10mg, bid, pill taken by mouth for 12 weeks
DRUGPlaceboplacebo pill, bid for 12 weeks

Timeline

Start date
2011-09-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2011-09-30
Last updated
2014-06-16
Results posted
2014-06-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01444300. Inclusion in this directory is not an endorsement.