NCT01356940

A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis

A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Brown, Theodore R., M.D., MPH · Individual
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis

Detailed description

This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dalfampridine ER	dalfampridine ER 10mg bid for 4 weeks
DRUG	placebo	identical placebo tablet administered bid for four weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-05-20
• Last updated: 2018-10-31
• Results posted: 2015-04-09

Locations

1 site across 1 country: United States