Back to resultsStudy to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine. (MILESTONE℠)
Primary Purpose
Post-ischemic Stroke
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dalfampridine-ER 7.5 mg
dalfampridine-ER 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Post-ischemic Stroke
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
Sites / Locations
- Acorda Site #117
- Acorda Site #109
- Acorda Site #170
- Acorda Site #138
- Acorda Site #105
- Acorda Site #142
- Acorda Site #153
- Acorda Site #151
- Acorda Site #163
- Acorda Site #124
- Acorda Site #110
- Acorda Site #149
- Acorda Site #130
- Acorda Site #115
- Acorda Site #119
- Acorda Site #147
- Acorda Site #128
- Acorda Site #184
- Acorda Site #103
- Acorda Site #133
- Acorda Site #161
- Acorda Site #106
- Acorda Site #181
- Acorda Site #171
- Acorda Site #148
- Acorda Site #188
- Acorda Site #156
- Acorda Site #146
- Acorda Site #150
- Acorda Site #175
- Acorda Site #136
- Acorda Site #121
- Acorda Site #123
- Acorda Site #164
- Acorda Site #159
- Acorda Site #101
- Acorda Site #111
- Acorda Site #140
- Acorda Site #131
- Acorda Site #177
- Acorda Site #172
- Acorda Site #179
- Acorda Site #114
- Acorda Site #166
- Acorda Site #167
- Acorda Site #162
- Acorda Site #154
- Acorda Site #132
- Acorda Site #137
- Acorda Site #116
- Acorda Site #152
- Acorda Site #168
- Acorda Site #126
- Acorda Site #122
- Acorda Site #144
- Acorda Site #157
- Acorda Site #113
- Acorda Site #165
- Acorda Site #108
- Acorda Site #182
- Acorda Site #176
- Acorda Site #107
- Acorda Site #203
- Acorda Site #202
- Acorda Site #201
- Acorda Site #204
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dalfampridine-ER 7.5 mg
dalfampridine-ER 10 mg
Arm Description
Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline on the Two-Minute Walk Test (2MinWT)
2 Minute Walk Test (2MinWT) and Change from Baseline by Visit
Change From Baseline on the 10 Meter Walk Test (10MWT)
10 Meter Walk Test (10MWT) and Change from Baseline by Visit
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.
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)
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)].
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."
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02422940
Brief Title
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
Acronym
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 .
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dalfampridine-ER 7.5 mg
Arm Type
Active Comparator
Arm Description
Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.
Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
Arm Title
dalfampridine-ER 10 mg
Arm Type
Active Comparator
Arm Description
Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.
Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
Intervention Type
Drug
Intervention Name(s)
dalfampridine-ER 7.5 mg
Intervention Type
Drug
Intervention Name(s)
dalfampridine-ER 10 mg
Other Intervention Name(s)
Ampyra™
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline on the Two-Minute Walk Test (2MinWT)
Description
2 Minute Walk Test (2MinWT) and Change from Baseline by Visit
Time Frame
Day 1, up to 12 months
Title
Change From Baseline on the 10 Meter Walk Test (10MWT)
Description
10 Meter Walk Test (10MWT) and Change from Baseline by Visit
Time Frame
Day 1, up to 12 months
Title
Change From Baseline on the Timed up and Go (TUG) Test
Description
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.
Time Frame
Day 1, up to 12 months
Title
Change From Baseline on the Walking Impact Scale (Walk-12)
Description
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)
Time Frame
Day 1, up to 12 months
Title
Change From Baseline on the Stroke Impact Scale (SIS)
Description
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)].
Time Frame
Day 1, up to 12 months
Title
Subject Global Impression (SGI)
Description
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."
Time Frame
Visit 8 (Month 12)
Title
Change From Baseline on the 12-item Health Survey (SF-12)
Description
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.
Time Frame
Day 1, up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Roberts, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #117
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Acorda Site #109
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Acorda Site #170
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Acorda Site #138
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Acorda Site #105
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Acorda Site #142
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Acorda Site #153
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Acorda Site #151
City
San Diego
State/Province
California
ZIP/Postal Code
921018466
Country
United States
Facility Name
Acorda Site #163
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Acorda Site #124
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Acorda Site #110
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Acorda Site #149
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Acorda Site #130
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Acorda Site #115
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Acorda Site #119
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33441
Country
United States
Facility Name
Acorda Site #147
City
Gainesville
State/Province
Florida
ZIP/Postal Code
326100236
Country
United States
Facility Name
Acorda Site #128
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Acorda Site #184
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Acorda Site #103
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Acorda Site #133
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Acorda Site #161
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Acorda Site #106
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Acorda Site #181
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Acorda Site #171
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Acorda Site #148
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Acorda Site #188
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Acorda Site #156
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
Acorda Site #146
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Acorda Site #150
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Acorda Site #175
City
Fulton
State/Province
Maryland
ZIP/Postal Code
20759
Country
United States
Facility Name
Acorda Site #136
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Acorda Site #121
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Acorda Site #123
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Acorda Site #164
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Acorda Site #159
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Acorda Site #101
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Acorda Site #111
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Acorda Site #140
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Acorda Site #131
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Acorda Site #177
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Acorda Site #172
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Acorda Site #179
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Acorda Site #114
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Acorda Site #166
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Acorda Site #167
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Acorda Site #162
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Acorda Site #154
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
276076010
Country
United States
Facility Name
Acorda Site #132
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Acorda Site #137
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Acorda Site #116
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Acorda Site #152
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Acorda Site #168
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Acorda Site #126
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Acorda Site #122
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Acorda Site #144
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Acorda Site #157
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Acorda Site #113
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Acorda Site #165
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Acorda Site #108
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #182
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22043
Country
United States
Facility Name
Acorda Site #176
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Acorda Site #107
City
Spokane
State/Province
Washington
ZIP/Postal Code
992021330
Country
United States
Facility Name
Acorda Site #203
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B0C7
Country
Canada
Facility Name
Acorda Site #202
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H4K4
Country
Canada
Facility Name
Acorda Site #201
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
Acorda Site #204
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
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