A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke "MILESTONE℠"

Completed

Phase 3 Results N/A

Update History

28 Jul '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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
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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
1 Jun '16
A location was updated in Gilbert.
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The overall status was removed for Acorda Site #117.
A location was updated in Berkeley.
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The overall status was removed for Acorda Site #109.
A location was updated in Long Beach.
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The overall status was removed for Acorda Site #138.
A location was updated in Newport Beach.
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The overall status was removed for Acorda Site #105.
A location was updated in Oceanside.
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The overall status was removed for Acorda Site #170.
A location was updated in Pasadena.
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The overall status was removed for Acorda Site #142.
A location was updated in Sacramento.
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The overall status was removed for Acorda Site #153.
A location was updated in San Diego.
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The overall status was removed for Acorda Site #151.
A location was updated in San Diego.
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The overall status was removed for Acorda Site #163.
A location was updated in Colorado Springs.
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The overall status was removed for Acorda Site #124.
A location was updated in Danbury.
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The overall status was removed for Acorda Site #110.
A location was updated in Fairfield.
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The overall status was removed for Acorda Site #149.
A location was updated in Stamford.
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The overall status was removed for Acorda Site #130.
A location was updated in Atlantis.
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The overall status was removed for Acorda Site #115.
A location was updated in Deerfield Beach.
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The overall status was removed for Acorda Site #119.
A location was updated in Gainesville.
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The overall status was removed for Acorda Site #147.
A location was updated in Hialeah.
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The overall status was removed for Acorda Site #128.
A location was updated in Jacksonville.
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The overall status was removed for Acorda Site #143.
A location was updated in Miami.
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The overall status was removed for Acorda Site #103.
A location was updated in Miami.
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The overall status was removed for Acorda Site #133.
A location was updated in Naples.
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The overall status was removed for Acorda Site #161.
A location was updated in Sunrise.
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The overall status was removed for Acorda Site #145.
A location was updated in Tampa.
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The overall status was removed for Acorda Site #106.
A location was updated in Atlanta.
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The overall status was removed for Acorda Site #186.
A location was updated in Kailua.
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The overall status was removed for Acorda Site #181.
A location was updated in Chicago.
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The overall status was removed for Acorda Site #171.
A location was updated in Avon.
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The overall status was removed for Acorda Site #148.
A location was updated in Franklin.
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The overall status was removed for Acorda Site #156.
A location was updated in Ft. Wayne.
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The overall status was removed for Acorda Site #188.
A location was updated in Lexington.
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The overall status was removed for Acorda Site #146.
A location was updated in New Orleans.
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The overall status was removed for Acorda Site #150.
A location was updated in Fulton.
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The overall status was removed for Acorda Site #175.
A location was updated in Boston.
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The overall status was removed for Acorda Site #136.
A location was updated in Boston.
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The overall status was removed for Acorda Site #121.
A location was updated in Bingham Farms.
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The overall status was removed for Acorda Site #164.
A location was updated in Detroit.
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The overall status was removed for Acorda Site #127.
A location was updated in East Lansing.
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The overall status was removed for Acorda Site #123.
A location was updated in Grand Rapids.
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The overall status was removed for Acorda Site #159.
A location was updated in Kansas City.
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The overall status was removed for Acorda Site #101.
A location was updated in Great Falls.
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The overall status was removed for Acorda Site #111.
A location was updated in Reno.
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The overall status was removed for Acorda Site #140.
A location was updated in New Brunswick.
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The overall status was removed for Acorda Site #131.
A location was updated in Stratford.
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The overall status was removed for Acorda Site #177.
A location was updated in New York.
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The overall status was removed for Acorda Site #172.
A location was updated in New York.
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The overall status was removed for Acorda Site #102.
A location was updated in Patchogue.
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The overall status was removed for Acorda Site #179.
A location was updated in White Plains.
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The overall status was removed for Acorda Site #114.
A location was updated in Durham.
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The overall status was removed for Acorda Site #167.
A location was updated in Mooresville.
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The overall status was removed for Acorda Site #162.
A location was updated in Raleigh.
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The overall status was removed for Acorda Site #154.
A location was updated in Winston-Salem.
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The overall status was removed for Acorda Site #132.
A location was updated in Bellevue.
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The overall status was removed for Acorda Site #187.
A location was updated in Cleveland.
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The overall status was removed for Acorda Site #160.
A location was updated in Columbus.
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The overall status was removed for Acorda Site #137.
A location was updated in Dayton.
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The overall status was removed for Acorda Site #116.
A location was updated in Corvallis.
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The overall status was removed for Acorda Site #152.
A location was updated in Portland.
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The overall status was removed for Acorda Site #168.
A location was updated in Portland.
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The overall status was removed for Acorda Site #126.
A location was updated in Abington.
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The overall status was removed for Acorda Site #158.
A location was updated in Philadelphia.
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The overall status was removed for Acorda Site #122.
A location was updated in Providence.
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The overall status was removed for Acorda Site #144.
A location was updated in Memphis.
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The overall status was removed for Acorda Site #157.
A location was updated in Dallas.
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The overall status was removed for Acorda Site #113.
A location was updated in Dallas.
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The overall status was removed for Acorda Site #165.
A location was updated in Houston.
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The overall status was removed for Acorda Site #108.
A location was updated in Alexandria.
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The overall status was removed for Acorda Site #182.
A location was updated in Richmond.
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The overall status was removed for Acorda Site #176.
A location was updated in Spokane.
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The overall status was removed for Acorda Site #107.
A location was updated in Fredericton.
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The overall status was removed for Acorda Site #203.
A location was updated in Halifax.
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The overall status was removed for Acorda Site #202.
A location was updated in Greenfield Park.
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The overall status was removed for Acorda Site #201.
A location was updated in Montréal.
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The overall status was removed for Acorda Site #204.
21 Nov '15
A location was updated in San Diego.
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The overall status was removed for Acorda Site #163.
A location was updated in Hialeah.
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The overall status was removed for Acorda Site #128.
A location was updated in Kailua.
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The overall status was removed for Acorda Site #181.
A location was updated in New York.
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The overall status was removed for Acorda Site #172.
A location was updated in Patchogue.
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The overall status was removed for Acorda Site #179.
A location was updated in Chapel Hill.
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The overall status was updated to "Recruiting" at Acorda Site #166.
A location was updated in Cleveland.
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The overall status was removed for Acorda Site #160.
A location was updated in Houston.
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The overall status was removed for Acorda Site #108.
A location was updated in Spokane.
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The overall status was updated to "Recruiting" at Acorda Site #107.
A location was updated in Fredericton.
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The overall status was removed for Acorda Site #203.
A location was updated in Montréal.
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The overall status was removed for Acorda Site #204.
23 Sep '15
A location was updated in Berkeley.
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The overall status was removed for Acorda Site #109.
A location was updated in Newport Beach.
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The overall status was removed for Acorda Site #105.
A location was updated in Oceanside.
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The overall status was removed for Acorda Site #170.
A location was updated in San Diego.
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The overall status was removed for Acorda Site #151.
A location was updated in Hialeah.
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The overall status was removed for Acorda Site #128.
A location was updated in Naples.
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The overall status was removed for Acorda Site #161.
A location was updated in Sunrise.
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The overall status was removed for Acorda Site #145.
A location was updated in Chicago.
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The overall status was removed for Acorda Site #171.
A location was updated in New Orleans.
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The overall status was removed for Acorda Site #150.
A location was updated in Worcester.
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The overall status was updated to "Recruiting" at Acorda Site #120.
A location was updated in Bingham Farms.
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The overall status was removed for Acorda Site #164.
A location was updated in East Lansing.
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The overall status was removed for Acorda Site #123.
A location was updated in Grand Rapids.
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The overall status was removed for Acorda Site #159.
A location was updated in West Haverstraw.
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The overall status was updated to "Recruiting" at Acorda Site #118.
A location was updated in Durham.
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The overall status was removed for Acorda Site #167.
A location was updated in Portland.
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The overall status was removed for Acorda Site #126.
A location was updated in Portland.
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The overall status was removed for Acorda Site #168.
A location was updated in Abington.
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The overall status was removed for Acorda Site #158.
12 Dec '14
Trial name was updated.
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A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke