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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)

NCT01535664 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2013-10-14

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Prometrika, LLC

    collaborator INDUSTRY

  • BCS Consulting, Inc.

    collaborator INDUSTRY

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Gabriel Pardo, MD · OMRF Multiple Sclerosis Center of Excellence

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535664 on ClinicalTrials.gov