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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)

NCT ID: NCT01535664

Last Updated: 2013-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Longitudinal study design

Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis MS

Study Design

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Observational Model Type

COHORT

Study Groups

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dalfampridine-ER 10mg

Subjects with MS taking dalfampridine-ER 10mg and considered to be responders

Withdrawal of dalfampridine-ER 10mg

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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Ampyra®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prometrika, LLC

INDUSTRY

Sponsor Role collaborator

BCS Consulting, Inc.

INDUSTRY

Sponsor Role collaborator

Acorda Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Pardo, MD

Role: PRINCIPAL_INVESTIGATOR

OMRF Multiple Sclerosis Center of Excellence

Locations

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OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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AMP-MS-1008

Identifier Type: -

Identifier Source: org_study_id