Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

Post-ischemic Stroke Clinical Trial

— MILESTONE?  

Official title:

An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02422940
• Other study ID #: DALF-PS-1029
• Status: Terminated
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2018
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Description:

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 294
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Completion of the DALF-PS-1016 study

• Providing informed consent to continue into the DALF-PS-1029 long-term extension study

• Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

Key Exclusion Criteria:

• Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study

• Calculated creatinine clearance of = 50 mL/minute at the time of enrollment into the long-term extension study

Related Conditions & MeSH terms

• Ischemia
• Post-ischemic Stroke
• Stroke

Intervention

Drug:
• dalfampridine-ER 7.5 mg

• dalfampridine-ER 10 mg

Locations

Country	Name	City	State
Canada	Acorda Site #203	Fredericton	New Brunswick
Canada	Acorda Site #201	Greenfield Park	Quebec
Canada	Acorda Site #202	Halifax	Nova Scotia
Canada	Acorda Site #204	Montréal	Quebec
United States	Acorda Site #115	Atlantis	Florida
United States	Acorda Site #148	Avon	Indiana
United States	Acorda Site #109	Berkeley	California
United States	Acorda Site #121	Boston	Massachusetts
United States	Acorda Site #136	Boston	Massachusetts
United States	Acorda Site #170	Carlsbad	California
United States	Acorda Site #166	Chapel Hill	North Carolina
United States	Acorda Site #171	Chicago	Illinois
United States	Acorda Site #124	Colorado Springs	Colorado
United States	Acorda Site #137	Columbus	Ohio
United States	Acorda Site #152	Corvallis	Oregon
United States	Acorda Site #113	Dallas	Texas
United States	Acorda Site #165	Dallas	Texas
United States	Acorda Site #110	Danbury	Connecticut
United States	Acorda Site #116	Dayton	Ohio
United States	Acorda Site #119	Deerfield Beach	Florida
United States	Acorda Site #167	Durham	North Carolina
United States	Acorda Site #123	East Lansing	Michigan
United States	Acorda Site #149	Fairfield	Connecticut
United States	Acorda Site #182	Falls Church	Virginia
United States	Acorda Site #164	Farmington Hills	Michigan
United States	Acorda Site #188	Fort Wayne	Indiana
United States	Acorda Site #156	Franklin	Indiana
United States	Acorda Site #175	Fulton	Maryland
United States	Acorda Site #147	Gainesville	Florida
United States	Acorda Site #117	Gilbert	Arizona
United States	Acorda Site #159	Grand Rapids	Michigan
United States	Acorda Site #111	Great Falls	Montana
United States	Acorda Site #128	Hialeah	Florida
United States	Acorda Site #181	Honolulu	Hawaii
United States	Acorda Site #108	Houston	Texas
United States	Acorda Site #184	Jacksonville	Florida
United States	Acorda Site #101	Kansas City	Missouri
United States	Acorda Site #146	Lexington	Kentucky
United States	Acorda Site #138	Long Beach	California
United States	Acorda Site #157	Memphis	Tennessee
United States	Acorda Site #103	Miami	Florida
United States	Acorda Site #133	Miami	Florida
United States	Acorda Site #162	Mooresville	North Carolina
United States	Acorda Site #161	Naples	Florida
United States	Acorda Site #131	New Brunswick	New Jersey
United States	Acorda Site #150	New Orleans	Louisiana
United States	Acorda Site #172	New York	New York
United States	Acorda Site #105	Newport Beach	California
United States	Acorda Site #142	Pasadena	California
United States	Acorda Site #179	Patchogue	New York
United States	Acorda Site #122	Philadelphia	Pennsylvania
United States	Acorda Site #126	Portland	Oregon
United States	Acorda Site #168	Portland	Oregon
United States	Acorda Site #144	Providence	Rhode Island
United States	Acorda Site #154	Raleigh	North Carolina
United States	Acorda Site #140	Reno	Nevada
United States	Acorda Site #176	Richmond	Virginia
United States	Acorda Site #153	Sacramento	California
United States	Acorda Site #151	San Diego	California
United States	Acorda Site #163	San Diego	California
United States	Acorda Site #107	Spokane	Washington
United States	Acorda Site #130	Stamford	Connecticut
United States	Acorda Site #177	Stratford	New Jersey
United States	Acorda Site #106	Tampa	Florida
United States	Acorda Site #114	White Plains	New York
United States	Acorda Site #132	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.	This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.	up to 12 months
Secondary	Change From Baseline on the Two-Minute Walk Test (2MinWT)	2 Minute Walk Test (2MinWT) and Change from Baseline by Visit	Day 1, up to 12 months
Secondary	Change From Baseline on the 10 Meter Walk Test (10MWT)	10 Meter Walk Test (10MWT) and Change from Baseline by Visit	Day 1, up to 12 months
Secondary	Change From Baseline on the Timed up and Go (TUG) Test	The TUG measures mobility and balance and can predict the risk of falls. This test, which was initially called the Get-up and Go test, is considered a measure of dynamic balance. The subject is asked to stand up from a chair, walk 10 feet at a comfortable pace, turn around and be seated. The Timed Up and Go (TUG) is measured in seconds. There will be one practice test and then the timed test. Only the timed test will be analyzed at each visit time point. Reciprocal transformation may be performed if the time values are markedly skewed.	Day 1, up to 12 months
Secondary	Change From Baseline on the Walking Impact Scale (Walk-12)	The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility. Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)	Day 1, up to 12 months
Secondary	Change From Baseline on the Stroke Impact Scale (SIS)	The SIS consists of 59 items grouped in 8 domains: strength, hand function, activities of daily living (ADL) / instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. The subject is asked to rate the level of difficulty in performing each item in the preceding week. Each item is scored on a 5-point scale ranging from 1 (inability to complete the item) to 5 (no difficulty experienced at all). For each domain, the SIS score will be calculated by summing all the items within the domain and transforming into a scale with a range of 0 to 100 as follows: SIS Score = 100 * [(Actual raw score - Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)].	Day 1, up to 12 months
Secondary	Subject Global Impression (SGI)	The Subject Global Impression (SGI) is single item measure of treatment response that asks the subject to rate the effects of the investigational drug on his or her overall walking ability using a 7 point scale ranging from 1 = "Terrible" to 7 = "Delighted."	Visit 8 (Month 12)
Secondary	Change From Baseline on the 12-item Health Survey (SF-12)	The SF-12 v2 (4-week recall) is a general health-related quality-of-life profile measure consisting of 12 items. The SF-12 Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores will be derived and normed to a general United States population for score algorithm. The normalized PCS and MCS scores will be calculated at baseline, Month 12, and subsequent visits.; SF-12 is a Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	Day 1, up to 12 months