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: August 8, 2013
Last verified: August 2013

February 7, 2012
August 8, 2013
January 2012
May 2012   (final data collection date for primary outcome measure)
  • 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and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ] [ Designated as safety issue: No ]

    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.

  • 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and Reinitiation of Dalfampridine-ER 10mg [ Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11) ] [ Designated as safety issue: No ]

    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.

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.
Complete list of historical versions of study NCT01535664 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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.
  • 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) ] [ 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.

    A larger walking distance is indicative of better performance.

  • 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) ] [ 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 population

    A higher walking speed is indicative of better performance

  • 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
Not Provided
Not Provided
 
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)
An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS

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.

Longitudinal study design

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

MS Population

Multiple Sclerosis
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®
dalfampridine-ER 10mg
Subjects with MS taking dalfampridine-ER 10mg and considered to be responders
Intervention: Other: Withdrawal of dalfampridine-ER 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01535664
AMP-MS-1008
No
Acorda Therapeutics
Acorda Therapeutics
  • Prometrika, LLC
  • BCS Consulting, Inc.
Principal Investigator: Gabriel Pardo, MD OMRF Multiple Sclerosis Center of Excellence
Acorda Therapeutics
August 2013

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