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)

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Withdrawal of dalfampridine-ER 10mg

• Registration Number: NCT01535664
• Lead Sponsor: Acorda Therapeutics

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.

Detailed Description

Longitudinal study design

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Results First Submitted: 2013-05-28
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Results First Posted: 2013-10-14
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dalfampridine-ER 10mg	Withdrawal of dalfampridine-ER 10mg	Subjects with MS taking dalfampridine-ER 10mg and considered to be responders

Primary Outcome Measures

Name	Time	Method
Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)	The co-primary efficacy variable was overall gait.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.
Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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

Name	Time	Method
Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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
Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.
Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg	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.

Trial Locations

Locations (1)

OMRF Multiple Sclerosis Center of Excellence; 🇺🇸 Oklahoma City, Oklahoma, United States