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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)

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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Other: Withdrawal of dalfampridine-ER 10mg
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dalfampridine-ER 10mg
Subjects with MS taking dalfampridine-ER 10mg
 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®

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MS Population

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535664

Locations
United States, Oklahoma
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Acorda Therapeutics
Prometrika, LLC
BCS Consulting, Inc.
Investigators
Principal Investigator: Gabriel Pardo, MD OMRF Multiple Sclerosis Center of Excellence
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01535664     History of Changes
Other Study ID Numbers: AMP-MS-1008
Study First Received: February 7, 2012
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Acorda Therapeutics:
Multiple Sclerosis
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013