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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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

Other trials in Canada

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.

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 groups in NCT02422940
Study groupRoleWhat they receive
dalfampridine-ER 7.5 mgActive comparatorDalfampridine-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 mgActive comparatorDalfampridine-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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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.

  1. First posted22 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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)
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
Data monitoring committee
Yes

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.

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