Post-ischemic Stroke
Conditions
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.
Interventions
DRUGdalfampridine-ER 7.5 mg
DRUGdalfampridine-ER 10 mg
Sponsors
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | up to 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the 10 Meter Walk Test (10MWT) | Day 1, up to 12 months | 10 Meter Walk Test (10MWT) and Change from Baseline by Visit |
| Change From Baseline on the Timed up and Go (TUG) Test | Day 1, up to 12 months | 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) | Day 1, up to 12 months | 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 Two-Minute Walk Test (2MinWT) | Day 1, up to 12 months | 2 Minute Walk Test (2MinWT) and Change from Baseline by Visit |
| Subject Global Impression (SGI) | Visit 8 (Month 12) | 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) | Day 1, up to 12 months | 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. |
| Change From Baseline on the Stroke Impact Scale (SIS) | Day 1, up to 12 months | 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 \* \[(Actual raw score - Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)\]. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dalfampridine-ER 7.5 mg 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 7.5 mg | 152 |
| Dalfampridine-ER 10 mg 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.
dalfampridine-ER 10 mg | 142 |
| Total | 294 |
Baseline characteristics
| Characteristic | Dalfampridine-ER 7.5 mg | Dalfampridine-ER 10 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants | 142 Participants | 294 Participants |
| Age, Continuous | 62.1 years STANDARD_DEVIATION 10.87 | 64.6 years STANDARD_DEVIATION 10.32 | 63.3 years STANDARD_DEVIATION 10.67 |
| Region of Enrollment Canada | 8 Participants | 9 Participants | 17 Participants |
| Region of Enrollment United States | 144 Participants | 133 Participants | 277 Participants |
| Sex: Female, Male Female | 54 Participants | 50 Participants | 104 Participants |
| Sex: Female, Male Male | 98 Participants | 92 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 151 | 0 / 142 |
| other Total, other adverse events | 102 / 151 | 99 / 142 |
| serious Total, serious adverse events | 14 / 151 | 8 / 142 |
Outcome results
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.
Time frame: up to 12 months
Population: The Safety Population of 293 subjects included all subjects who received at least one dose of study treatment.~\*One subject was randomized but discontinued the study prior to receiving double-blind study treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalfampridine-ER 7.5 mg | 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. | Subjects by Maximum Severity (Mild) | 45 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects by Maximum Severity (Severe) | 14 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects with at Least One Serious TEAE | 14 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects with at least One TEAEA leading to Discon | 12 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects by Maximum Severity (Moderate) | 43 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects who Died Due to a TEAE | 1 Participants |
| Dalfampridine-ER 7.5 mg | 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. | Subjects with at Least One TEAE | 102 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects who Died Due to a TEAE | 0 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects with at Least One TEAE | 99 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects with at Least One Serious TEAE | 8 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects by Maximum Severity (Mild) | 45 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects by Maximum Severity (Moderate) | 43 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects by Maximum Severity (Severe) | 11 Participants |
| Dalfampridine-ER 10 mg | 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. | Subjects with at least One TEAEA leading to Discon | 7 Participants |
Secondary
Change From Baseline on the 10 Meter Walk Test (10MWT)
10 Meter Walk Test (10MWT) and Change from Baseline by Visit
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 3 (Month 1) Change from Baseline | 0.03 Meter /second | Standard Deviation 0.124 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 6 (Month 6) Actual Value | 1.01 Meter /second | Standard Deviation 0.497 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 2 (Day 15) Change from Baseline | 0.05 Meter /second | Standard Deviation 0.118 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 6 (Month 6) Change from Baseline | 0.06 Meter /second | Standard Deviation 0.145 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 4 (Month 2) Actual Value | 0.99 Meter /second | Standard Deviation 0.502 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 7 (Month 9) Actual Value | 0.99 Meter /second | Standard Deviation 0.582 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 2 (Day 15) Actual Value | 0.97 Meter /second | Standard Deviation 0.498 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 7 (Month 9) Change from Baseline | 0.08 Meter /second | Standard Deviation 0.205 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 4 (Month 2) Change from Baseline | 0.06 Meter /second | Standard Deviation 0.136 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 8 (Month 12) Actual Value | 1.05 Meter /second | Standard Deviation 0.563 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 3 (Month 1) Actual Value | 0.96 Meter /second | Standard Deviation 0.47 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 8 (Month 12) Change from Baseline | 0.07 Meter /second | Standard Deviation 0.198 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Baseline | 0.92 Meter /second | Standard Deviation 0.454 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Final Visit - Actual Value | 1.04 Meter /second | Standard Deviation 0.534 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 5 (Month 3) Change from Baseline | 0.05 Meter /second | Standard Deviation 0.146 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Final Visit - Change from Baseline | 0.04 Meter /second | Standard Deviation 0.199 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 5 (Month 3) Actual Value | 0.95 Meter /second | Standard Deviation 0.489 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Final Visit - Change from Baseline | -0.03 Meter /second | Standard Deviation 0.263 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Baseline | 0.89 Meter /second | Standard Deviation 0.472 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 2 (Day 15) Actual Value | 0.94 Meter /second | Standard Deviation 0.494 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 2 (Day 15) Change from Baseline | 0.05 Meter /second | Standard Deviation 0.124 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 3 (Month 1) Actual Value | 0.98 Meter /second | Standard Deviation 0.494 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 3 (Month 1) Change from Baseline | 0.06 Meter /second | Standard Deviation 0.122 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 4 (Month 2) Actual Value | 0.98 Meter /second | Standard Deviation 0.503 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 4 (Month 2) Change from Baseline | 0.08 Meter /second | Standard Deviation 0.134 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 5 (Month 3) Actual Value | 1.00 Meter /second | Standard Deviation 0.488 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 5 (Month 3) Change from Baseline | 0.08 Meter /second | Standard Deviation 0.167 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 6 (Month 6) Actual Value | 0.99 Meter /second | Standard Deviation 0.456 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 6 (Month 6) Change from Baseline | 0.07 Meter /second | Standard Deviation 0.124 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 7 (Month 9) Actual Value | 1.06 Meter /second | Standard Deviation 0.4 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 7 (Month 9) Change from Baseline | 0.08 Meter /second | Standard Deviation 0.145 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 8 (Month 12) Actual Value | 1.08 Meter /second | Standard Deviation 0.414 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Visit 8 (Month 12) Change from Baseline | 0.06 Meter /second | Standard Deviation 0.238 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 10 Meter Walk Test (10MWT) | Final Visit - Actual Value | 0.91 Meter /second | Standard Deviation 0.425 |
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.
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Baseline | 54.2 score on a scale | Standard Deviation 11.26 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Visit 8 - (Month 12) Actual | 50.5 score on a scale | Standard Deviation 11.83 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Visit 8 - (Month 12) Change from Baseline | -4.3 score on a scale | Standard Deviation 10.48 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Baseline | 36.2 score on a scale | Standard Deviation 9.11 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Visit 8 - (Month 12) Actual | 37.3 score on a scale | Standard Deviation 8.12 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Visit 8 - (Month 12) Change from Baseline | 2.7 score on a scale | Standard Deviation 7.42 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Visit 8 - (Month 12) Actual | 34.4 score on a scale | Standard Deviation 10.55 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Baseline | 54.4 score on a scale | Standard Deviation 10 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Baseline | 37.0 score on a scale | Standard Deviation 8.64 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Visit 8 - (Month 12) Actual | 54.5 score on a scale | Standard Deviation 11.6 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | PCS - Visit 8 - (Month 12) Change from Baseline | -2.3 score on a scale | Standard Deviation 7.5 |
| Dalfampridine-ER 10 mg | Change From Baseline on the 12-item Health Survey (SF-12) | MCS - Visit 8 - (Month 12) Change from Baseline | -2.4 score on a scale | Standard Deviation 9.28 |
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 \* \[(Actual raw score - Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)\].
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 6 Change from Baseline | -1.01 score on a scale | Standard Deviation 15.56 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 6 Actual | 72.8 score on a scale | Standard Deviation 18.57 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 6 Change from Baseline | 0.4 score on a scale | Standard Deviation 9.13 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 8 Actual | 72.3 score on a scale | Standard Deviation 18.64 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 8 Change from Baseline | 1.7 score on a scale | Standard Deviation 10.49 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication - Baseline | 88.6 score on a scale | Standard Deviation 16.76 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 6 Actual | 88.7 score on a scale | Standard Deviation 16.43 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 6 Change from Baseline | -0.1 score on a scale | Standard Deviation 9.85 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 8 Actual | 83.6 score on a scale | Standard Deviation 22.74 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 8 Change from Baseline | -1.2 score on a scale | Standard Deviation 12.33 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion - Baseline | 67.3 score on a scale | Standard Deviation 13.08 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 6 Actual | 66.5 score on a scale | Standard Deviation 12.88 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL - Baseline | 71.8 score on a scale | Standard Deviation 18.38 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 8 Actual | 64.5 score on a scale | Standard Deviation 14.94 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 8 Change from Baseline | -2.6 score on a scale | Standard Deviation 12.77 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function - Baseline | 45.9 score on a scale | Standard Deviation 34.01 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 6 Actual | 47.3 score on a scale | Standard Deviation 34.81 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 6 Change from Baseline | 4.6 score on a scale | Standard Deviation 17.57 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 8 Actual | 46.2 score on a scale | Standard Deviation 34.66 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 8 Change from Baseline | 4.3 score on a scale | Standard Deviation 20.12 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking - Baseline | 82.8 score on a scale | Standard Deviation 19.45 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 6 Actual | 84.0 score on a scale | Standard Deviation 19.32 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 6 Change from Baseline | 0.9 score on a scale | Standard Deviation 9.1 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 8 Actual | 80.7 score on a scale | Standard Deviation 20.51 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 8 Change from Baseline | 0.5 score on a scale | Standard Deviation 10.95 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility - Baseline | 71.7 score on a scale | Standard Deviation 18.98 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 6 Actual | 74.5 score on a scale | Standard Deviation 18.52 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 6 Change from Baseline | 1.4 score on a scale | Standard Deviation 9.76 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 8 Actual | 70.8 score on a scale | Standard Deviation 16.66 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 8 Change from Baseline | 3.5 score on a scale | Standard Deviation 13.56 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation - Baseline | 64.8 score on a scale | Standard Deviation 26.08 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 6 Actual | 69.6 score on a scale | Standard Deviation 24.73 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 6 Change from Baseline | 3.4 score on a scale | Standard Deviation 20.03 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 8 Actual | 65.3 score on a scale | Standard Deviation 23.95 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 8 Change from Baseline | 4.3 score on a scale | Standard Deviation 18.86 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Score (SIS 16) - Baseline | 63.6 score on a scale | Standard Deviation 10.01 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Visit 6 Actual | 65.1 score on a scale | Standard Deviation 10.14 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dim. Visit 6 Change from Baseline | 0.7 score on a scale | Standard Deviation 5.13 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Visit 8 Actual | 64.0 score on a scale | Standard Deviation 9.52 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dim. Visit 8 Change from Baseline | 1.5 score on a scale | Standard Deviation 6.73 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength - Baseline | 53.4 score on a scale | Standard Deviation 23.02 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 6 Actual | 51.5 score on a scale | Standard Deviation 24.46 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 6 Change from Baseline | -0.9 score on a scale | Standard Deviation 15.85 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 8 Actual | 48.5 score on a scale | Standard Deviation 19.16 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 8 Change from Baseline | -1.1 score on a scale | Standard Deviation 17.91 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery - Baseline | 60.3 score on a scale | Standard Deviation 21.42 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery - Visit 6 Actual | 64.0 score on a scale | Standard Deviation 20.72 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 6 Change from Baseline | 2.8 score on a scale | Standard Deviation 15.08 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 8 Actual | 62.4 score on a scale | Standard Deviation 22.16 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 8 Change from Baseline | 0.6 score on a scale | Standard Deviation 13.16 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dim. Visit 6 Change from Baseline | -0.6 score on a scale | Standard Deviation 5.31 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL - Baseline | 75.1 score on a scale | Standard Deviation 16.56 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility - Baseline | 72.8 score on a scale | Standard Deviation 19.07 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 6 Actual | 77.0 score on a scale | Standard Deviation 16.14 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 8 Actual | 67.4 score on a scale | Standard Deviation 18.03 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 6 Change from Baseline | -0.2 score on a scale | Standard Deviation 8.99 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 6 Actual | 74.2 score on a scale | Standard Deviation 18.59 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 8 Actual | 73.8 score on a scale | Standard Deviation 15.14 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Visit 8 Actual | 62.8 score on a scale | Standard Deviation 9.72 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS ADL/IADL Visit 8 Change from Baseline | -0.3 score on a scale | Standard Deviation 8.35 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 6 Change from Baseline | -0.9 score on a scale | Standard Deviation 11.58 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication - Baseline | 88.3 score on a scale | Standard Deviation 17.81 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 8 Change from Baseline | -1.3 score on a scale | Standard Deviation 22.27 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 6 Actual | 88.6 score on a scale | Standard Deviation 15.38 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 8 Actual | 68.6 score on a scale | Standard Deviation 19.46 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 6 Change from Baseline | 0.3 score on a scale | Standard Deviation 11.87 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dim. Visit 8 Change from Baseline | -1.3 score on a scale | Standard Deviation 4.92 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 8 Actual | 89.7 score on a scale | Standard Deviation 16.47 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Mobility Visit 8 Change from Baseline | -2.2 score on a scale | Standard Deviation 11.17 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Communication Visit 8 Change from Baseline | -2.5 score on a scale | Standard Deviation 8.97 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 6 Change from Baseline | 1.5 score on a scale | Standard Deviation 12.08 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion - Baseline | 68.9 score on a scale | Standard Deviation 13.16 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation - Baseline | 68.8 score on a scale | Standard Deviation 22.85 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 6 Actual | 65.7 score on a scale | Standard Deviation 12.08 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength - Baseline | 53.3 score on a scale | Standard Deviation 22.34 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 6 Change from Baseline | -2.7 score on a scale | Standard Deviation 14.26 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 6 Actual | 70.7 score on a scale | Standard Deviation 21.95 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 8 Actual | 67.0 score on a scale | Standard Deviation 14.37 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery - Baseline | 65.0 score on a scale | Standard Deviation 17.03 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Emotion Visit 8 Change from Baseline | 3.8 score on a scale | Standard Deviation 13.48 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 6 Change from Baseline | 1.4 score on a scale | Standard Deviation 15.97 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function - Baseline | 48.4 score on a scale | Standard Deviation 34.79 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 6 Actual | 52.8 score on a scale | Standard Deviation 21.25 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 6 Actual | 52.3 score on a scale | Standard Deviation 32.3 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 8 Actual | 65.8 score on a scale | Standard Deviation 24.65 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 6 Change from Baseline | 1.3 score on a scale | Standard Deviation 14.51 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery Visit 8 Change from Baseline | 1.8 score on a scale | Standard Deviation 13.32 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 8 Actual | 54.0 score on a scale | Standard Deviation 31.95 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Participation Visit 8 Change from Baseline | -3.1 score on a scale | Standard Deviation 19.26 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Hand Function Visit 8 Change from Baseline | 3.3 score on a scale | Standard Deviation 16.4 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 6 Change from Baseline | 0.0 score on a scale | Standard Deviation 19.45 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking - Baseline | 82.8 score on a scale | Standard Deviation 19.91 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Score (SIS 16) - Baseline | 64.5 score on a scale | Standard Deviation 9.94 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 6 Actual | 84.9 score on a scale | Standard Deviation 17.35 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | Stroke Recovery - Visit 6 Actual | 66.4 score on a scale | Standard Deviation 17.19 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 6 Change from Baseline | 0.9 score on a scale | Standard Deviation 10.86 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Physical Dimension Visit 6 Actual | 65.1 score on a scale | Standard Deviation 9.66 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 8 Actual | 87.1 score on a scale | Standard Deviation 17.83 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Strength Visit 8 Actual | 51.8 score on a scale | Standard Deviation 21.54 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Stroke Impact Scale (SIS) | SIS Memory & Thinking Visit 8 Change from Baseline | -1.0 score on a scale | Standard Deviation 12.39 |
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.
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 2 (Day 15) Actual Value | 18.59 Seconds | Standard Deviation 30.461 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 6 (Month 6) Actual Value | 17.75 Seconds | Standard Deviation 31.394 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 4 (Month 2) Actual Value | 17.57 Seconds | Standard Deviation 22.351 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 6 (Month 6) Change from Baseline | 0.33 Seconds | Standard Deviation 9.273 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 3 (Month 1) Actual Value | 17.28 Seconds | Standard Deviation 21.165 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 7 (Month 9) Actual Value | 22.93 Seconds | Standard Deviation 39.918 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 4 (Month 2) Change from Baseline | -0.45 Seconds | Standard Deviation 3.644 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 7 (Month 9) Change from Baseline | 1.66 Seconds | Standard Deviation 11.085 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 2 (Day 15) Change from Baseline | 0.67 Seconds | Standard Deviation 12.64 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 8 (Month 12) Actual Value | 16.80 Seconds | Standard Deviation 13.724 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 5 (Month 3) Actual Value | 18.10 Seconds | Standard Deviation 26.829 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 8 (Month 12) Change from Baseline | 0.33 Seconds | Standard Deviation 4.536 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 3 (Month 1) Change from Baseline | -0.59 Seconds | Standard Deviation 3.215 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Final Visit - Actual Value | 17.38 Seconds | Standard Deviation 15.967 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 5 (Month 3) Change from Baseline | 0.05 Seconds | Standard Deviation 7.321 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Final Visit - Change from Baseline | 1.34 Seconds | Standard Deviation 6.416 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Timed up and Go (TUG) Test | Baseline | 17.92 Seconds | Standard Deviation 19.899 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Final Visit - Change from Baseline | 1.25 Seconds | Standard Deviation 6.914 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Baseline | 20.16 Seconds | Standard Deviation 18.587 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 2 (Day 15) Actual Value | 19.82 Seconds | Standard Deviation 20.019 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 2 (Day 15) Change from Baseline | -0.40 Seconds | Standard Deviation 4.844 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 3 (Month 1) Actual Value | 18.76 Seconds | Standard Deviation 19.267 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 3 (Month 1) Change from Baseline | -0.61 Seconds | Standard Deviation 7.329 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 4 (Month 2) Actual Value | 18.49 Seconds | Standard Deviation 16.563 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 4 (Month 2) Change from Baseline | -1.32 Seconds | Standard Deviation 4.816 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 5 (Month 3) Actual Value | 17.39 Seconds | Standard Deviation 16.509 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 5 (Month 3) Change from Baseline | -1.60 Seconds | Standard Deviation 4.323 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 6 (Month 6) Actual Value | 17.07 Seconds | Standard Deviation 15.532 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 6 (Month 6) Change from Baseline | -1.36 Seconds | Standard Deviation 4.74 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 7 (Month 9) Actual Value | 15.85 Seconds | Standard Deviation 14.085 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 7 (Month 9) Change from Baseline | -1.08 Seconds | Standard Deviation 3.452 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 8 (Month 12) Actual Value | 15.17 Seconds | Standard Deviation 15.635 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Visit 8 (Month 12) Change from Baseline | -0.50 Seconds | Standard Deviation 2.606 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Timed up and Go (TUG) Test | Final Visit - Actual Value | 19.21 Seconds | Standard Deviation 20.596 |
Secondary
Change From Baseline on the Two-Minute Walk Test (2MinWT)
2 Minute Walk Test (2MinWT) and Change from Baseline by Visit
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 6 (Month 6) Change from Baseline | 16.38 Feet | Standard Deviation 38.767 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Baseline | 309.59 Feet | Standard Deviation 132.956 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 2 (Day 15) Actual Value | 319.24 Feet | Standard Deviation 135.072 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 2 (Day 15) Change from Baseline | 9.72 Feet | Standard Deviation 34.898 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 3 (Month 1) Actual Value | 322.95 Feet | Standard Deviation 136.511 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 3 (Month 1) Change from Baseline | 10.81 Feet | Standard Deviation 40.457 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 4 (Month 2) Actual Value | 328.01 Feet | Standard Deviation 139.437 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 4 (Month 2) Change from Baseline | 16.67 Feet | Standard Deviation 34.512 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 5 (Month 3) Actual Value | 323.29 Feet | Standard Deviation 136.815 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 5 (Month 3) Change from Baseline | 15.44 Feet | Standard Deviation 41.635 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 6 (Month 6) Actual Value | 335.28 Feet | Standard Deviation 128.117 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 7 (Month 9) Actual Value | 312.98 Feet | Standard Deviation 136.536 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 7 (Month 9) Change from Baseline | 21.88 Feet | Standard Deviation 45.327 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 8 (Month 12) Actual Value | 330.07 Feet | Standard Deviation 144.749 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 8 (Month 12) Change from Baseline | 23.65 Feet | Standard Deviation 50.899 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Final Visit - Actual Value | 320.34 Feet | Standard Deviation 136.425 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Final Visit - Change from Baseline | 20.23 Feet | Standard Deviation 50.991 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Final Visit - Change from Baseline | 9.88 Feet | Standard Deviation 51.867 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 5 (Month 3) Change from Baseline | 16.99 Feet | Standard Deviation 41.207 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Baseline | 297.41 Feet | Standard Deviation 143.722 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 8 (Month 12) Actual Value | 360.90 Feet | Standard Deviation 107.895 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 2 (Day 15) Actual Value | 312.08 Feet | Standard Deviation 146.818 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 6 (Month 6) Actual Value | 321.28 Feet | Standard Deviation 133.484 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 2 (Day 15) Change from Baseline | 14.27 Feet | Standard Deviation 34.824 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 6 (Month 6) Change from Baseline | 72 Feet | Standard Deviation 10 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 3 (Month 1) Actual Value | 317.96 Feet | Standard Deviation 146.419 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Final Visit - Actual Value | 318.48 Feet | Standard Deviation 126.718 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 3 (Month 1) Change from Baseline | 14.48 Feet | Standard Deviation 39.961 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 7 (Month 9) Actual Value | 342.24 Feet | Standard Deviation 129.673 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 4 (Month 2) Actual Value | 318.98 Feet | Standard Deviation 147.429 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 8 (Month 12) Change from Baseline | 19.98 Feet | Standard Deviation 34.067 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 4 (Month 2) Change from Baseline | 17.48 Feet | Standard Deviation 37.385 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 7 (Month 9) Change from Baseline | 19.25 Feet | Standard Deviation 33.597 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Two-Minute Walk Test (2MinWT) | Visit 5 (Month 3) Actual Value | 331.77 Feet | Standard Deviation 140.872 |
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)
Time frame: Day 1, up to 12 months
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 2 (Day 15) Actual Value | 47.00 units on a scale | Standard Deviation 25.86 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 8 (Month 12) Actual Value | 45.47 units on a scale | Standard Deviation 23.405 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 6 (Month 6) Actual Value | 42.72 units on a scale | Standard Deviation 23.649 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 8 (Month 12) Change from Baseline | -6.13 units on a scale | Standard Deviation 16.047 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 2 (Day 15) Change from Baseline | -0.57 units on a scale | Standard Deviation 13.081 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Final Visit - Actual Value | 44.21 units on a scale | Standard Deviation 24.976 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 6 (Month 6) Change from Baseline | -1.95 units on a scale | Standard Deviation 13.247 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Final Visit - Change from Baseline | -9.18 units on a scale | Standard Deviation 17.097 |
| Dalfampridine-ER 7.5 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Baseline | 47.37 units on a scale | Standard Deviation 26.933 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Final Visit - Change from Baseline | -1.90 units on a scale | Standard Deviation 12.53 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Baseline | 49.78 units on a scale | Standard Deviation 26.583 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 2 (Day 15) Actual Value | 45.95 units on a scale | Standard Deviation 25.275 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 2 (Day 15) Change from Baseline | -3.92 units on a scale | Standard Deviation 14.235 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 6 (Month 6) Actual Value | 48.14 units on a scale | Standard Deviation 25.484 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 6 (Month 6) Change from Baseline | -2.40 units on a scale | Standard Deviation 14.457 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 8 (Month 12) Actual Value | 49.67 units on a scale | Standard Deviation 24.501 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Visit 8 (Month 12) Change from Baseline | -5.75 units on a scale | Standard Deviation 12.986 |
| Dalfampridine-ER 10 mg | Change From Baseline on the Walking Impact Scale (Walk-12) | Final Visit - Actual Value | 49.00 units on a scale | Standard Deviation 25.078 |
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.
Time frame: Visit 8 (Month 12)
Population: The study was conducted in patients with chronic walking deficits from an ischemic stroke. These were the only participants to finish the SGI study due to study termination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 1 - Terrible | 0 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 7 - Delighted | 6 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 6 - Pleased | 7 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 5 - Somewhat Satisfied | 6 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 4 - Neutral/Mixed | 12 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 3 - Somewhat Dissatisfied | 1 Participants |
| Dalfampridine-ER 7.5 mg | Subject Global Impression (SGI) | 2 - Unhappy | 1 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 1 - Terrible | 1 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 4 - Neutral/Mixed | 5 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 7 - Delighted | 2 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 2 - Unhappy | 0 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 6 - Pleased | 8 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 3 - Somewhat Dissatisfied | 0 Participants |
| Dalfampridine-ER 10 mg | Subject Global Impression (SGI) | 5 - Somewhat Satisfied | 8 Participants |