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)

NCT01535664 | Completed Results

• 1 other identifier: AMP-MS-1008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS

Outcome Measures

Primary Outcomes (2)

• 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  11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

dalfampridine-ER 10mg

Subjects with MS taking dalfampridine-ER 10mg and considered to be responders

Other: Withdrawal of dalfampridine-ER 10mg

Interventions

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)

Also known as: Ampyra®

dalfampridine-ER 10mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS Population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead
• Prometrika, LLC: collaborator
• BCS Consulting, Inc.: collaborator

Study Sites (1)

OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gustavo Suarez, MD
• Organization: Acorda Therapeutics, Inc.

gsuarez@acorda.com

(914) 326-5394

Study Officials

• Gabriel Pardo, MD

  OMRF Multiple Sclerosis Center of Excellence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 20, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 14, 2013
• Results First Posted: October 14, 2013

Record last verified: 2013-08

Locations

US (1)