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)

This study has been completed.

Sponsor:

Collaborators:

Prometrika, LLC

BCS Consulting, Inc.

Information provided by (Responsible Party):

Acorda Therapeutics

ClinicalTrials.gov Identifier:

NCT01535664

First received: February 7, 2012

Last updated: July 30, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2012

Last Updated Date

July 30, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

measuring change in overall gait and balance parameters after withdrawal of dalfampridine-ER 10mg [ Time Frame: Day-7 (visit 1), Day 1 (visit 2), Day 5 (visit 3), Day 11 (visit 4), and Day 15 (visit 5) ] [ Designated as safety issue: No ]

Gait and balance parameters will be measured using a NeuroCom Smart™ Balance Master. It is a machine that provides objective assessments and retraining of the sensory and voluntary motor control of balance with visual feedback on either a stable or unstable support surface and in a stable or dynamic visual environment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01535664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes on the Berg's Balance Scale (BBS) [ Time Frame: Day-7 (visit 1), Day 1 (visit 2), Day 5 (visit 3), Day 11 (visit 4), and Day 15 (visit 5) ] [ Designated as safety issue: No ]
The BBS evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task).
Two minute walk test (2MWT) [ Time Frame: Day-7 (visit 1), Day 1 (visit 2), Day 5 (visit 3), Day 11 (visit 4), and Day 15 (visit 5) ] [ Designated as safety issue: No ]
Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.
Timed 25 foot walk test (T25FW) [ Time Frame: Day-7 (visit 1), Day 1 (visit 2), Day 5 (visit 3), Day 11 (visit 4), and Day 15 (visit 5) ] [ Designated as safety issue: No ]
The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS poulation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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

Brief 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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

MS Population

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

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)

Other Name: Ampyra®

Study Group/Cohort (s)

dalfampridine-ER 10mg

Subjects with MS taking dalfampridine-ER 10mg

Intervention: Other: Withdrawal of dalfampridine-ER 10mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of multiple sclerosis
Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
No history of seizures except simple febrile seizures

Exclusion Criteria:

Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods
Subject who is pregnant or breastfeeding

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01535664

Other Study ID Numbers ^ICMJE

AMP-MS-1008

Has Data Monitoring Committee

Responsible Party

Acorda Therapeutics

Study Sponsor ^ICMJE

Acorda Therapeutics

Collaborators ^ICMJE

Prometrika, LLC
BCS Consulting, Inc.

Investigators ^ICMJE

Principal Investigator:

Gabriel Pardo, MD

OMRF Multiple Sclerosis Center of Excellence

Information Provided By

Acorda Therapeutics

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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