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NCT Number: NCT01535664

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)

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, 73104, United States

About this study

Longitudinal study design

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Withdrawal of dalfampridine-ER 10mg

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)

Other names: Ampyra®

Primary outcomes

  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    Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Collaborators

  • BCS Consulting, Inc.
  • Prometrika, LLC

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 20, 2012
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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