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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)

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ClinicalTrials.gov Identifier: NCT01535664
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Withdrawal of dalfampridine-ER 10mg Phase 2

Detailed Description:
Longitudinal study design

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Official Title: An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS
Study Start Date : January 2012
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
dalfampridine-ER 10mg
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
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)
Other Name: Ampyra®


Outcome Measures

Primary Outcome Measures :
  1. Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ]

    The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).

    ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).

    Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.


  2. Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ]

    The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).

    Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)

    Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.



Secondary Outcome Measures :
  1. Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ]
    The BBS is a 14-item scale that 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) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.

  2. Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ]

    Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.

    A larger walking distance is indicative of better performance.


  3. Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ]

    The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population

    A higher walking speed is indicative of better performance



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01535664     History of Changes
Other Study ID Numbers: AMP-MS-1008
First Posted: February 20, 2012    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: August 2013

Keywords provided by Acorda Therapeutics:
Multiple Sclerosis
MS

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