CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Dalfampridine +1 moredrug
Likely dose
Dalfampridine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01444300
NCT01444300Phase 2Completed

Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study

Oregon Health and Science University·interventional·Posted Sep 30, 2011·Updated Jun 16, 2014

In Brief

A Phase 2 clinical trial evaluating Dalfampridine and Placebo for Multiple Sclerosis and Fatigue. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAcorda Therapeutics

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.8 years ago

Interventions

Dalfampridinedrug

10mg, bid, pill taken by mouth for 12 weeks

Placebodrug

placebo pill, bid for 12 weeks