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

NCT ID: NCT02271217

Last Updated: 2018-06-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

dalfampridine-ER 7.5 mg

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Group Type ACTIVE_COMPARATOR

dalfampridine-ER 7.5mg

Intervention Type DRUG

dalfampridine-ER 10mg

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Group Type ACTIVE_COMPARATOR

dalfampridine-ER 10mg

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

dalfampridine-ER 7.5mg

Intervention Type DRUG

dalfampridine-ER 10mg

Intervention Type DRUG

Other Intervention Names

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Ampyra

Eligibility Criteria

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Inclusion Criteria

* 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:

1. obvious slowness of movement assigned primarily to the stroke
2. use of an assistive walking device such as a cane or walker
3. 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

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acorda Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Roberts, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

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Acorda Site #117

Gilbert, Arizona, United States

Site Status

Acorda Site #109

Berkeley, California, United States

Site Status

Acorda Site #138

Long Beach, California, United States

Site Status

Acorda Site #105

Newport Beach, California, United States

Site Status

Acorda Site #170

Oceanside, California, United States

Site Status

Acorda Site #142

Pasadena, California, United States

Site Status

Acorda Site #153

Sacramento, California, United States

Site Status

Acorda Site #151

San Diego, California, United States

Site Status

Acorda Site #163

San Diego, California, United States

Site Status

Acorda Site #124

Colorado Springs, Colorado, United States

Site Status

Acorda Site #110

Danbury, Connecticut, United States

Site Status

Acorda Site #149

Fairfield, Connecticut, United States

Site Status

Acorda Site #130

Stamford, Connecticut, United States

Site Status

Acorda Site #115

Atlantis, Florida, United States

Site Status

Acorda Site #119

Deerfield Beach, Florida, United States

Site Status

Acorda Site #147

Gainesville, Florida, United States

Site Status

Acorda Site #128

Hialeah, Florida, United States

Site Status

Acorda Site #143

Jacksonville, Florida, United States

Site Status

Acorda Site #103

Miami, Florida, United States

Site Status

Acorda Site #133

Miami, Florida, United States

Site Status

Acorda Site #161

Naples, Florida, United States

Site Status

Acorda Site #145

Sunrise, Florida, United States

Site Status

Acorda Site #106

Tampa, Florida, United States

Site Status

Acorda Site #186

Atlanta, Georgia, United States

Site Status

Acorda Site #181

Kailua, Hawaii, United States

Site Status

Acorda Site #171

Chicago, Illinois, United States

Site Status

Acorda Site #148

Avon, Indiana, United States

Site Status

Acorda Site #188

Fort Wayne, Indiana, United States

Site Status

Acorda Site #156

Franklin, Indiana, United States

Site Status

Acorda Site #146

Lexington, Kentucky, United States

Site Status

Acorda Site #150

New Orleans, Louisiana, United States

Site Status

Acorda Site #175

Fulton, Maryland, United States

Site Status

Acorda Site #136

Boston, Massachusetts, United States

Site Status

Acorda Site #121

Boston, Massachusetts, United States

Site Status

Acorda Site #120

Worcester, Massachusetts, United States

Site Status

Acorda Site #164

Bingham Farms, Michigan, United States

Site Status

Acorda Site #127

Detroit, Michigan, United States

Site Status

Acorda Site #123

East Lansing, Michigan, United States

Site Status

Acorda Site #159

Grand Rapids, Michigan, United States

Site Status

Acorda Site #101

Kansas City, Missouri, United States

Site Status

Acorda Site #111

Great Falls, Montana, United States

Site Status

Acorda Site #140

Reno, Nevada, United States

Site Status

Acorda Site #131

New Brunswick, New Jersey, United States

Site Status

Acorda Site #177

Stratford, New Jersey, United States

Site Status

Acorda Site #172

New York, New York, United States

Site Status

Acorda Site #102

New York, New York, United States

Site Status

Acorda Site #179

Patchogue, New York, United States

Site Status

Acorda Site #114

White Plains, New York, United States

Site Status

Acorda Site #166

Chapel Hill, North Carolina, United States

Site Status

Acorda Site #167

Durham, North Carolina, United States

Site Status

Acorda Site #162

Mooresville, North Carolina, United States

Site Status

Acorda Site #154

Raleigh, North Carolina, United States

Site Status

Acorda Site #132

Winston-Salem, North Carolina, United States

Site Status

Acorda Site #187

Bellevue, Ohio, United States

Site Status

Acorda Site #160

Cleveland, Ohio, United States

Site Status

Acorda Site #137

Columbus, Ohio, United States

Site Status

Acorda Site #116

Dayton, Ohio, United States

Site Status

Acorda Site #152

Corvallis, Oregon, United States

Site Status

Acorda Site #168

Portland, Oregon, United States

Site Status

Acorda Site #126

Portland, Oregon, United States

Site Status

Acorda Site #158

Abington, Pennsylvania, United States

Site Status

Acorda Site #122

Philadelphia, Pennsylvania, United States

Site Status

Acorda Site #144

Providence, Rhode Island, United States

Site Status

Acorda Site #157

Memphis, Tennessee, United States

Site Status

Acorda Site #113

Dallas, Texas, United States

Site Status

Acorda Site #165

Dallas, Texas, United States

Site Status

Acorda Site #108

Houston, Texas, United States

Site Status

Acorda Site #182

Alexandria, Virginia, United States

Site Status

Acorda Site #176

Richmond, Virginia, United States

Site Status

Acorda Site #107

Spokane, Washington, United States

Site Status

Acorda Site #203

Fredericton, New Brunswick, Canada

Site Status

Acorda Site #202

Halifax, Nova Scotia, Canada

Site Status

Acorda Site #201

Greenfield Park, Quebec, Canada

Site Status

Acorda Site #204

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 32651338 (View on PubMed)

Related Links

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http://milestone.acordatrials.com/

Click here for potential enrollment or for more information about this study: DALF-PS-1016

Other Identifiers

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DALF-PS-1016

Identifier Type: -

Identifier Source: org_study_id

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