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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Withdrawal of dalfampridine-ER 10mg

Detailed Description

Longitudinal study design

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OMRF Multiple Sclerosis Center of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MS Population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Ampyra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Collaborators: Prometrika, LLC; BCS Consulting, Inc.
• Investigators: Principal Investigator: Gabriel Pardo, MD, OMRF Multiple Sclerosis Center of Excellence

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: AMP-MS-1008