Post-ischemic StrokePhase 3MILESTONE℠NCT02422940
Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
A Phase 3 study testing dalfampridine-ER 7.5 mg and dalfampridine-ER 10 mg in people with Post-ischemic Stroke, run by Acorda Therapeutics at 66 sites in 2 countries.
Trial summary
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ischemic Stroke
- What is being tested?
- dalfampridine-ER 7.5 mg and dalfampridine-ER 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 66 sitesin 2 countries
- Study dates
- Apr 2015to Jan 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
United States62 sites
Acorda Site #115
Atlantis, Florida, 33462
Acorda Site #148
Avon, Indiana, 46123
Acorda Site #109
Berkeley, California, 94705
Acorda Site #136
Boston, Massachusetts, 02114
Acorda Site #121
Boston, Massachusetts, 02118
Acorda Site #170
Carlsbad, California, 92011
Acorda Site #166
Chapel Hill, North Carolina, 27599
Acorda Site #171
Chicago, Illinois, 60611
Acorda Site #124
Colorado Springs, Colorado, 80907
Acorda Site #137
Columbus, Ohio, 43210
Acorda Site #152
Corvallis, Oregon, 97330
Acorda Site #113
Dallas, Texas, 75214
Acorda Site #165
Dallas, Texas, 75246
Acorda Site #110
Danbury, Connecticut, 06810
Acorda Site #116
Dayton, Ohio, 45417
Acorda Site #119
Deerfield Beach, Florida, 33441
Acorda Site #167
Durham, North Carolina, 27710
Acorda Site #123
East Lansing, Michigan, 48824
Acorda Site #149
Fairfield, Connecticut, 06824
Acorda Site #182
Falls Church, Virginia, 22043
Acorda Site #164
Farmington Hills, Michigan, 48334
Acorda Site #188
Fort Wayne, Indiana, 46804
Acorda Site #156
Franklin, Indiana, 46131
Acorda Site #175
Fulton, Maryland, 20759
Acorda Site #147
Gainesville, Florida, 326100236
Acorda Site #117
Gilbert, Arizona, 85234
Acorda Site #159
Grand Rapids, Michigan, 49503
Acorda Site #111
Great Falls, Montana, 59405
Acorda Site #128
Hialeah, Florida, 33012
Acorda Site #181
Honolulu, Hawaii, 96817
Acorda Site #108
Houston, Texas, 77030
Acorda Site #184
Jacksonville, Florida, 32277
Acorda Site #101
Kansas City, Missouri, 64132
Acorda Site #146
Lexington, Kentucky, 40513
Acorda Site #138
Long Beach, California, 90806
Acorda Site #157
Memphis, Tennessee, 38163
Acorda Site #103
Miami, Florida, 33142
Acorda Site #133
Miami, Florida, 33175
Acorda Site #162
Mooresville, North Carolina, 28117
Acorda Site #161
Naples, Florida, 34102
Acorda Site #131
New Brunswick, New Jersey, 08901
Acorda Site #150
New Orleans, Louisiana, 70121
Acorda Site #172
New York, New York, 10029
Acorda Site #105
Newport Beach, California, 92663
Acorda Site #142
Pasadena, California, 91105
Acorda Site #179
Patchogue, New York, 11772
Acorda Site #122
Philadelphia, Pennsylvania, 19104
Acorda Site #168
Portland, Oregon, 97225
Acorda Site #126
Portland, Oregon, 97239
Acorda Site #144
Providence, Rhode Island, 02903
Acorda Site #154
Raleigh, North Carolina, 276076010
Acorda Site #140
Reno, Nevada, 89502
Acorda Site #176
Richmond, Virginia, 23298
Acorda Site #153
Sacramento, California, 95823
Acorda Site #151
San Diego, California, 921018466
Acorda Site #163
San Diego, California, 92123
Acorda Site #107
Spokane, Washington, 992021330
Acorda Site #130
Stamford, Connecticut, 06905
Acorda Site #177
Stratford, New Jersey, 08084
Acorda Site #106
Tampa, Florida, 33606
Acorda Site #114
White Plains, New York, 10605
Acorda Site #132
Winston-Salem, North Carolina, 27103
Canada4 sites
Acorda Site #203
Fredericton, New Brunswick, E3B0C7
Acorda Site #201
Greenfield Park, Quebec, J4V2H1
Acorda Site #202
Halifax, Nova Scotia, B3H4K4
Acorda Site #204
Montreal, Quebec, H3G1A4
About this study
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 .
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.
Read the 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.
- Conditions
- Post-ischemic Stroke
- Being tested
- dalfampridine-ER 7.5 mg, dalfampridine-ER 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalfampridine-ER 7.5 mgDrug
dalfampridine-ER 10 mgDrug
Also called Ampyra™
| Study group | Role | What they receive |
|---|---|---|
| dalfampridine-ER 7.5 mg | Active comparator | 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. Receives: Drug: dalfampridine-ER 7.5 mg |
| dalfampridine-ER 10 mg | Active comparator | 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. Receives: Drug: dalfampridine-ER 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (7)
Change From Baseline on the Two-Minute Walk Test (2MinWT)
2 Minute Walk Test (2MinWT) and Change from Baseline by Visit
Measured: Day 1, up to 12 months
Change From Baseline on the 10 Meter Walk Test (10MWT)
10 Meter Walk Test (10MWT) and Change from Baseline by Visit
Measured: Day 1, up to 12 months
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.
Measured: Day 1, up to 12 months
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)
Measured: Day 1, up to 12 months
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)].
Measured: Day 1, up to 12 months
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."
Measured: Visit 8 (Month 12)
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.
Measured: Day 1, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holly Roberts, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422940
- Sponsor's protocol ID
- DALF-PS-1029
- Acronym
- MILESTONE℠
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2015
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT02422940
- Acronym / sponsor ID
- MILESTONE℠ / DALF-PS-1029
- Conditions
- Post-ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalfampridine-ER 7.5 mg | Active comparator | Drug: dalfampridine-ER 7.5 mgDalfampridine-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 | Active comparator | Drug: dalfampridine-ER 10 mgDalfampridine-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalfampridine-ER 7.5 mg | Drug | dalfampridine-ER 7.5 mg |
| dalfampridine-ER 10 mgAlso: Ampyra™ | Drug | dalfampridine-ER 10 mg |
Primary outcome
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.
Time frame: 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.
7 secondary outcomes
Change From Baseline on the Two-Minute Walk Test (2MinWT)
Time frame: Day 1, up to 12 months
Change From Baseline on the 10 Meter Walk Test (10MWT)
Time frame: Day 1, up to 12 months
Change From Baseline on the Timed up and Go (TUG) Test
Time frame: Day 1, up to 12 months
Change From Baseline on the Walking Impact Scale (Walk-12)
Time frame: Day 1, up to 12 months
Change From Baseline on the Stroke Impact Scale (SIS)
Time frame: Day 1, up to 12 months
Subject Global Impression (SGI)
Time frame: Visit 8 (Month 12)
Change From Baseline on the 12-item Health Survey (SF-12)
Time frame: Day 1, up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Neurological Rehabilitation and Neuroplasticity After Ischemic Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Roberts, MD study director
Acorda Therapeutics
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dalfampridine-ER 7.5 mg and dalfampridine-ER 10 mg in people with Post-ischemic Stroke, run by Acorda Therapeutics at 66 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.