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

Phase 3

Completed

Conditions: Post-Ischemic Stroke

Interventions: Drug: Placebo
Drug: dalfampridine-ER 7.5mg
Drug: dalfampridine-ER 10mg

Registration Number: NCT02271217

Lead Sponsor: Acorda Therapeutics

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 377

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
dalfampridine-ER 7.5 mg	dalfampridine-ER 7.5mg	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.
dalfampridine-ER 10mg	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)	Baseline, week 12	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)

Trial Locations

Locations (74): Acorda Site #109
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Berkeley, California, United States
Acorda Site #186
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Atlanta, Georgia, United States
Acorda Site #103
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Miami, Florida, United States
Acorda Site #136
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Boston, Massachusetts, United States
Acorda Site #133
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Miami, Florida, United States
Acorda Site #121
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Boston, Massachusetts, United States
Acorda Site #175
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Fulton, Maryland, United States
Acorda Site #203
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Fredericton, New Brunswick, Canada
Acorda Site #117
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Gilbert, Arizona, United States
Acorda Site #181
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Kailua, Hawaii, United States
Acorda Site #106
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Tampa, Florida, United States
Acorda Site #142
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Pasadena, California, United States
Acorda Site #138
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Long Beach, California, United States
Acorda Site #110
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Danbury, Connecticut, United States
Acorda Site #171
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Chicago, Illinois, United States
Acorda Site #157
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Memphis, Tennessee, United States
Acorda Site #152
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Corvallis, Oregon, United States
Acorda Site #168
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Portland, Oregon, United States
Acorda Site #172
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New York, New York, United States
Acorda Site #151
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San Diego, California, United States
Acorda Site #101
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Kansas City, Missouri, United States
Acorda Site #170
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Oceanside, California, United States
Acorda Site #102
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New York, New York, United States
Acorda Site #130
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Stamford, Connecticut, United States
Acorda Site #149
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Fairfield, Connecticut, United States
Acorda Site #124
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Colorado Springs, Colorado, United States
Acorda Site #147
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Gainesville, Florida, United States
Acorda Site #128
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Hialeah, Florida, United States
Acorda Site #188
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Fort Wayne, Indiana, United States
Acorda Site #148
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Avon, Indiana, United States
Acorda Site #156
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Franklin, Indiana, United States
Acorda Site #122
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Philadelphia, Pennsylvania, United States
Acorda Site #108
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Houston, Texas, United States
Acorda Site #126
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Portland, Oregon, United States
Acorda Site #116
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Dayton, Ohio, United States
Acorda Site #123
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East Lansing, Michigan, United States
Acorda Site #111
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Great Falls, Montana, United States
Acorda Site #187
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Bellevue, Ohio, United States
Acorda Site #137
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Columbus, Ohio, United States
Acorda Site #201
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Greenfield Park, Quebec, Canada
Acorda Site #176
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Richmond, Virginia, United States
Acorda Site #204
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Montréal, Quebec, Canada
Acorda Site #144
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Providence, Rhode Island, United States
Acorda Site #131
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New Brunswick, New Jersey, United States
Acorda Site #167
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Durham, North Carolina, United States
Acorda Site #158
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Abington, Pennsylvania, United States
Acorda Site #113
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Dallas, Texas, United States
Acorda Site #165
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Dallas, Texas, United States
Acorda Site #182
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Alexandria, Virginia, United States
Acorda Site #105
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Newport Beach, California, United States
Acorda Site #153
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Sacramento, California, United States
Acorda Site #163
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San Diego, California, United States
Acorda Site #115
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Atlantis, Florida, United States
Acorda Site #119
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Deerfield Beach, Florida, United States
Acorda Site #143
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Jacksonville, Florida, United States
Acorda Site #161
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Naples, Florida, United States
Acorda Site #145
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Sunrise, Florida, United States
Acorda Site #146
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Lexington, Kentucky, United States
Acorda Site #120
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Worcester, Massachusetts, United States
Acorda Site #127
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Detroit, Michigan, United States
Acorda Site #164
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Bingham Farms, Michigan, United States
Acorda Site #159
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Grand Rapids, Michigan, United States
Acorda Site #140
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Reno, Nevada, United States
Acorda Site #177
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Stratford, New Jersey, United States
Acorda Site #114
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White Plains, New York, United States
Acorda Site #166
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Chapel Hill, North Carolina, United States
Acorda Site #154
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Raleigh, North Carolina, United States
Acorda Site #162
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Mooresville, North Carolina, United States
Acorda Site #160
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Cleveland, Ohio, United States
Acorda Site #132
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Winston-Salem, North Carolina, United States
Acorda Site #107
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Spokane, Washington, United States
Acorda Site #202
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Halifax, Nova Scotia, Canada
Acorda Site #179
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Patchogue, New York, United States
Acorda Site #150
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New Orleans, Louisiana, United States