Clinical trial NCT02422940: Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
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 .
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-ischemic Stroke
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 12 months
Secondary outcomes:
measure: Change From Baseline on the Two-Minute Walk Test (2MinWT)
timeFrame: Day 1, up to 12 months
measure: Change From Baseline on the 10 Meter Walk Test (10MWT)
timeFrame: Day 1, up to 12 months
measure: Change From Baseline on the Timed up and Go (TUG) Test
timeFrame: Day 1, up to 12 months
measure: Change From Baseline on the Walking Impact Scale (Walk-12)
timeFrame: Day 1, up to 12 months
measure: Change From Baseline on the Stroke Impact Scale (SIS)
timeFrame: Day 1, up to 12 months
measure: Subject Global Impression (SGI)
timeFrame: Visit 8 (Month 12)
measure: Change From Baseline on the 12-item Health Survey (SF-12)
timeFrame: Day 1, up to 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Acorda Site #117
state: Arizona
city: Berkeley
country: United States
facility: Acorda Site #109
state: California
city: Carlsbad
country: United States
facility: Acorda Site #170
state: California
city: Long Beach
country: United States
facility: Acorda Site #138
state: California
city: Newport Beach
country: United States
facility: Acorda Site #105
state: California
city: Pasadena
country: United States
facility: Acorda Site #142
state: California
city: Sacramento
country: United States
facility: Acorda Site #153
state: California
city: San Diego
country: United States
facility: Acorda Site #151
state: California
city: San Diego
country: United States
facility: Acorda Site #163
state: California
city: Colorado Springs
country: United States
facility: Acorda Site #124
state: Colorado
city: Danbury
country: United States
facility: Acorda Site #110
state: Connecticut
city: Fairfield
country: United States
facility: Acorda Site #149
state: Connecticut
city: Stamford
country: United States
facility: Acorda Site #130
state: Connecticut
city: Atlantis
country: United States
facility: Acorda Site #115
state: Florida
city: Deerfield Beach
country: United States
facility: Acorda Site #119
state: Florida
city: Gainesville
country: United States
facility: Acorda Site #147
state: Florida
city: Hialeah
country: United States
facility: Acorda Site #128
state: Florida
city: Jacksonville
country: United States
facility: Acorda Site #184
state: Florida
city: Miami
country: United States
facility: Acorda Site #103
state: Florida
city: Miami
country: United States
facility: Acorda Site #133
state: Florida
city: Naples
country: United States
facility: Acorda Site #161
state: Florida
city: Tampa
country: United States
facility: Acorda Site #106
state: Florida
city: Honolulu
country: United States
facility: Acorda Site #181
state: Hawaii
city: Chicago
country: United States
facility: Acorda Site #171
state: Illinois
city: Avon
country: United States
facility: Acorda Site #148
state: Indiana
city: Fort Wayne
country: United States
facility: Acorda Site #188
state: Indiana
city: Franklin
country: United States
facility: Acorda Site #156
state: Indiana
city: Lexington
country: United States
facility: Acorda Site #146
state: Kentucky
city: New Orleans
country: United States
facility: Acorda Site #150
state: Louisiana
city: Fulton
country: United States
facility: Acorda Site #175
state: Maryland
city: Boston
country: United States
facility: Acorda Site #136
state: Massachusetts
city: Boston
country: United States
facility: Acorda Site #121
state: Massachusetts
city: East Lansing
country: United States
facility: Acorda Site #123
state: Michigan
city: Farmington Hills
country: United States
facility: Acorda Site #164
state: Michigan
city: Grand Rapids
country: United States
facility: Acorda Site #159
state: Michigan
city: Kansas City
country: United States
facility: Acorda Site #101
state: Missouri
city: Great Falls
country: United States
facility: Acorda Site #111
state: Montana
city: Reno
country: United States
facility: Acorda Site #140
state: Nevada
city: New Brunswick
country: United States
facility: Acorda Site #131
state: New Jersey
city: Stratford
country: United States
facility: Acorda Site #177
state: New Jersey
city: New York
country: United States
facility: Acorda Site #172
state: New York
city: Patchogue
country: United States
facility: Acorda Site #179
state: New York
city: White Plains
country: United States
facility: Acorda Site #114
state: New York
city: Chapel Hill
country: United States
facility: Acorda Site #166
state: North Carolina
city: Durham
country: United States
facility: Acorda Site #167
state: North Carolina
city: Mooresville
country: United States
facility: Acorda Site #162
state: North Carolina
city: Raleigh
country: United States
facility: Acorda Site #154
state: North Carolina
city: Winston-Salem
country: United States
facility: Acorda Site #132
state: North Carolina
city: Columbus
country: United States
facility: Acorda Site #137
state: Ohio
city: Dayton
country: United States
facility: Acorda Site #116
state: Ohio
city: Corvallis
country: United States
facility: Acorda Site #152
state: Oregon
city: Portland
country: United States
facility: Acorda Site #168
state: Oregon
city: Portland
country: United States
facility: Acorda Site #126
state: Oregon
city: Philadelphia
country: United States
facility: Acorda Site #122
state: Pennsylvania
city: Providence
country: United States
facility: Acorda Site #144
state: Rhode Island
city: Memphis
country: United States
facility: Acorda Site #157
state: Tennessee
city: Dallas
country: United States
facility: Acorda Site #113
state: Texas
city: Dallas
country: United States
facility: Acorda Site #165
state: Texas
city: Houston
country: United States
facility: Acorda Site #108
state: Texas
city: Falls Church
country: United States
facility: Acorda Site #182
state: Virginia
city: Richmond
country: United States
facility: Acorda Site #176
state: Virginia
city: Spokane
country: United States
facility: Acorda Site #107
state: Washington
city: Fredericton
country: Canada
facility: Acorda Site #203
state: New Brunswick
city: Halifax
country: Canada
facility: Acorda Site #202
state: Nova Scotia
city: Greenfield Park
country: Canada
facility: Acorda Site #201
state: Quebec
city: Montréal
country: Canada
facility: Acorda Site #204
state: Quebec
Study officials:
affiliation: Acorda Therapeutics
name: Holly Roberts, MD
role: STUDY_DIRECTOR
References: