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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422940
Recruitment Status : Terminated
First Posted : April 22, 2015
Results First Posted : August 8, 2018
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Brief Summary:
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Condition or disease Intervention/treatment Phase
Post-ischemic Stroke Drug: dalfampridine-ER 7.5 mg Drug: dalfampridine-ER 10 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Ampyra™




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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)

  5. 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)].

  6. 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."

  7. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422940


Locations
Show Show 66 study locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Holly Roberts, MD Acorda Therapeutics
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02422940    
Other Study ID Numbers: DALF-PS-1029
First Posted: April 22, 2015    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: January 22, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action