NCT01535664

An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

Detailed description

Longitudinal study design

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Withdrawal of dalfampridine-ER 10mg	Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion) * On drug Day-7 (visit 1) through Day 1 (visit 2) * Off drug Day 5±2 days (visit 3) through Day 11±2 days (visit 4) * On drug Day 15±2 days (visit 5)

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2012-02-20
• Last updated: 2013-10-14
• Results posted: 2013-10-14

Locations

1 site across 1 country: United States