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Post-Ischemic StrokePhase 3MILESTONE℠NCT02271217

A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.

A Phase 3 study testing dalfampridine-ER 7.5mg and dalfampridine-ER 10mg in people with Post-Ischemic Stroke, run by Acorda Therapeutics at 74 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke. 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 7.5mg and dalfampridine-ER 10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
377 participants
Where
74 sitesin 2 countries
Study dates
Dec 2014to Oct 2016
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

  • Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:
  • obvious slowness of movement assigned primarily to the stroke
  • use of an assistive walking device such as a cane or walker
  • Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
  • Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability
  • Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT
  • ≥ 6 months from occurrence of most recent stroke

Who cannot join

  • Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.
  • Woman who is pregnant, breastfeeding, or planning to become pregnant
  • History of seizures, except simple febrile seizures
  • Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
  • Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
  • Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
Show all 9Show fewer
  • Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
  • Botulinum toxin use within 2 months prior to the Screening Visit
  • Orthopedic surgical procedures in any of the extremities within the past 6 months

Trial locations and contacts

74 sites in 2 countries.

74 sites in 2 countries

United States70 sites

  • Acorda Site #158

    Abington, Pennsylvania, 19001

  • Acorda Site #182

    Alexandria, Virginia, 22310

  • Acorda Site #186

    Atlanta, Georgia, 30309

  • Acorda Site #115

    Atlantis, Florida, 33462

  • Acorda Site #148

    Avon, Indiana, 46123

  • Acorda Site #187

    Bellevue, Ohio, 44811

  • Acorda Site #109

    Berkeley, California, 94705

  • Acorda Site #164

    Bingham Farms, Michigan, 48025

  • Acorda Site #136

    Boston, Massachusetts, 02114

  • Acorda Site #121

    Boston, Massachusetts, 02118

  • Acorda Site #166

    Chapel Hill, North Carolina, 27599

  • Acorda Site #171

    Chicago, Illinois, 60611

  • Acorda Site #160

    Cleveland, Ohio, 44195

  • 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, 33064

  • Acorda Site #127

    Detroit, Michigan, 48201

  • Acorda Site #167

    Durham, North Carolina, 27705

  • Acorda Site #123

    East Lansing, Michigan, 48824

  • Acorda Site #149

    Fairfield, Connecticut, 06824

  • Acorda Site #188

    Fort Wayne, Indiana, 46805

  • Acorda Site #156

    Franklin, Indiana, 46131

  • Acorda Site #175

    Fulton, Maryland, 20759

  • Acorda Site #147

    Gainesville, Florida, 32611

  • 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 #108

    Houston, Texas, 77030

  • Acorda Site #143

    Jacksonville, Florida, 32209

  • Acorda Site #181

    Kailua, Hawaii, 96734

  • 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, 08903

  • Acorda Site #150

    New Orleans, Louisiana, 70121

  • Acorda Site #172

    New York, New York, 10029

  • Acorda Site #102

    New York, New York, 11220

  • Acorda Site #105

    Newport Beach, California, 92663

  • Acorda Site #170

    Oceanside, California, 92056

  • 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, 92103

  • 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 #145

    Sunrise, Florida, 33351

  • Acorda Site #106

    Tampa, Florida, 33606

  • Acorda Site #114

    White Plains, New York, 10605

  • Acorda Site #132

    Winston-Salem, North Carolina, 27103

  • Acorda Site #120

    Worcester, Massachusetts, 016052610

Other trials in United States

Canada4 sites

  • Acorda Site #203

    Fredericton, New Brunswick, E3B0C7

  • Acorda Site #201

    Greenfield Park, Quebec, J4V2G9

  • Acorda Site #202

    Halifax, Nova Scotia, B3H4K4

  • Acorda Site #204

    Montreal, Quebec, H3G1A4

Other trials in Canada

About this study

Official title: This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

Read the detailed description

This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Being tested
Placebo, dalfampridine-ER 7.5mg, dalfampridine-ER 10mg
Keywords
Post stroke, Ischemic stroke
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

  • dalfampridine-ER 7.5mgDrug

  • dalfampridine-ER 10mgDrug

    Also called Ampyra

Study groups in NCT02271217
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Receives: Drug: Placebo
dalfampridine-ER 7.5 mgActive comparatorSubjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Receives: Drug: dalfampridine-ER 7.5mg
dalfampridine-ER 10mgActive comparatorSubjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Receives: Drug: dalfampridine-ER 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12

    "The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".

    Measured: Week 12

Secondary outcomes (1)

  1. Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)

    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: Baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionSep 2016
  4. Study completionOct 2016

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
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02271217
Sponsor's protocol ID
DALF-PS-1016
Acronym
MILESTONE℠
Status last verified
Sep 2017
First submitted
20 Oct 2014
Last updated
7 Jun 2018
Data monitoring committee
Yes

Publications

  • Page SJ, Kasner SE, Bockbrader M, Goldstein M, Finklestein SP, Ning M, El-Feky WH, Wilson CA, Roberts H; all of the investigators involved in the MILESTONE study. A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke. Restor Neurol Neurosci. 2020;38(4):301-309. doi: 10.3233/RNN-201009.

    PubMed 32651338

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dalfampridine-ER 7.5mg and dalfampridine-ER 10mg in people with Post-Ischemic Stroke, run by Acorda Therapeutics at 74 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 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. Some participants in this study may receive a placebo. 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 4 Dec 2017). 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?

Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02271217, which also lists 1 linked publication.

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 7 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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