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)

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535664
• Other study ID #: AMP-MS-1008
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2012
• Last updated: August 8, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Longitudinal study design

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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)

Locations

Country	Name	City	State
United States	OMRF Multiple Sclerosis Center of Excellence	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Acorda Therapeutics	BCS Consulting, Inc., Prometrika, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No