Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine. (MILESTONE℠)

January 17, 2019 updated by: Acorda Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
294

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B0C7
        • Acorda Site #203
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H4K4
        • Acorda Site #202
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V2H1
        • Acorda Site #201
      • Montréal, Quebec, Canada, H3G1A4
        • Acorda Site #204
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Acorda Site #117
    • California
      • Berkeley, California, United States, 94705
        • Acorda Site #109
      • Carlsbad, California, United States, 92011
        • Acorda Site #170
      • Long Beach, California, United States, 90806
        • Acorda Site #138
      • Newport Beach, California, United States, 92663
        • Acorda Site #105
      • Pasadena, California, United States, 91105
        • Acorda Site #142
      • Sacramento, California, United States, 95823
        • Acorda Site #153
      • San Diego, California, United States, 92123
        • Acorda Site #163
      • San Diego, California, United States, 921018466
        • Acorda Site #151
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Acorda Site #124
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Acorda Site #110
      • Fairfield, Connecticut, United States, 06824
        • Acorda Site #149
      • Stamford, Connecticut, United States, 06905
        • Acorda Site #130
    • Florida
      • Atlantis, Florida, United States, 33462
        • Acorda Site #115
      • Deerfield Beach, Florida, United States, 33441
        • Acorda Site #119
      • Gainesville, Florida, United States, 326100236
        • Acorda Site #147
      • Hialeah, Florida, United States, 33012
        • Acorda Site #128
      • Jacksonville, Florida, United States, 32277
        • Acorda Site #184
      • Miami, Florida, United States, 33142
        • Acorda Site #103
      • Miami, Florida, United States, 33175
        • Acorda Site #133
      • Naples, Florida, United States, 34102
        • Acorda Site #161
      • Tampa, Florida, United States, 33606
        • Acorda Site #106
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Acorda Site #181
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Acorda Site #171
    • Indiana
      • Avon, Indiana, United States, 46123
        • Acorda Site #148
      • Fort Wayne, Indiana, United States, 46804
        • Acorda Site #188
      • Franklin, Indiana, United States, 46131
        • Acorda Site #156
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • Acorda Site #146
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Acorda Site #150
    • Maryland
      • Fulton, Maryland, United States, 20759
        • Acorda Site #175
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Acorda Site #136
      • Boston, Massachusetts, United States, 02118
        • Acorda Site #121
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Acorda Site #123
      • Farmington Hills, Michigan, United States, 48334
        • Acorda Site #164
      • Grand Rapids, Michigan, United States, 49503
        • Acorda Site #159
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Acorda Site #101
    • Montana
      • Great Falls, Montana, United States, 59405
        • Acorda Site #111
    • Nevada
      • Reno, Nevada, United States, 89502
        • Acorda Site #140
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Acorda Site #131
      • Stratford, New Jersey, United States, 08084
        • Acorda Site #177
    • New York
      • New York, New York, United States, 10029
        • Acorda Site #172
      • Patchogue, New York, United States, 11772
        • Acorda Site #179
      • White Plains, New York, United States, 10605
        • Acorda Site #114
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Acorda Site #166
      • Durham, North Carolina, United States, 27710
        • Acorda Site #167
      • Mooresville, North Carolina, United States, 28117
        • Acorda Site #162
      • Raleigh, North Carolina, United States, 276076010
        • Acorda Site #154
      • Winston-Salem, North Carolina, United States, 27103
        • Acorda Site #132
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Acorda Site #137
      • Dayton, Ohio, United States, 45417
        • Acorda Site #116
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Acorda Site #152
      • Portland, Oregon, United States, 97225
        • Acorda Site #168
      • Portland, Oregon, United States, 97239
        • Acorda Site #126
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Acorda Site #122
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Acorda Site #144
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Acorda Site #157
    • Texas
      • Dallas, Texas, United States, 75214
        • Acorda Site #113
      • Dallas, Texas, United States, 75246
        • Acorda Site #165
      • Houston, Texas, United States, 77030
        • Acorda Site #108
    • Virginia
      • Falls Church, Virginia, United States, 22043
        • Acorda Site #182
      • Richmond, Virginia, United States, 23298
        • Acorda Site #176
    • Washington
      • Spokane, Washington, United States, 992021330
        • Acorda Site #107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: dalfampridine-ER 7.5 mg
Active Comparator: 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.
Drug: dalfampridine-ER 10 mg
Other Names:
  • Ampyra™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline on the Two-Minute Walk Test (2MinWT)
Time Frame: Day 1, up to 12 months
2 Minute Walk Test (2MinWT) and Change from Baseline by Visit
Day 1, up to 12 months
Change From Baseline on the 10 Meter Walk Test (10MWT)
Time Frame: Day 1, up to 12 months
10 Meter Walk Test (10MWT) and Change from Baseline by Visit
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
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.
Day 1, up to 12 months
Change From Baseline on the Walking Impact Scale (Walk-12)
Time Frame: 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)
Day 1, up to 12 months
Change From Baseline on the Stroke Impact Scale (SIS)
Time Frame: 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)].
Day 1, up to 12 months
Subject Global Impression (SGI)
Time Frame: 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."
Visit 8 (Month 12)
Change From Baseline on the 12-item Health Survey (SF-12)
Time Frame: 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.
Day 1, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DALF-PS-1029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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