Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.
NCT ID: NCT02422940
Last Updated: 2019-01-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
294 participants
INTERVENTIONAL
2015-04-30
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
dalfampridine-ER 7.5 mg
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.
dalfampridine-ER 10 mg
Interventions
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dalfampridine-ER 7.5 mg
dalfampridine-ER 10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
18 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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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
Acorda Site #109
Berkeley, California, United States
Acorda Site #170
Carlsbad, California, United States
Acorda Site #138
Long Beach, California, United States
Acorda Site #105
Newport Beach, California, United States
Acorda Site #142
Pasadena, California, United States
Acorda Site #153
Sacramento, California, United States
Acorda Site #151
San Diego, California, United States
Acorda Site #163
San Diego, California, United States
Acorda Site #124
Colorado Springs, Colorado, United States
Acorda Site #110
Danbury, Connecticut, United States
Acorda Site #149
Fairfield, Connecticut, United States
Acorda Site #130
Stamford, Connecticut, United States
Acorda Site #115
Atlantis, Florida, United States
Acorda Site #119
Deerfield Beach, Florida, United States
Acorda Site #147
Gainesville, Florida, United States
Acorda Site #128
Hialeah, Florida, United States
Acorda Site #184
Jacksonville, Florida, United States
Acorda Site #103
Miami, Florida, United States
Acorda Site #133
Miami, Florida, United States
Acorda Site #161
Naples, Florida, United States
Acorda Site #106
Tampa, Florida, United States
Acorda Site #181
Honolulu, Hawaii, United States
Acorda Site #171
Chicago, Illinois, United States
Acorda Site #148
Avon, Indiana, United States
Acorda Site #188
Fort Wayne, Indiana, United States
Acorda Site #156
Franklin, Indiana, United States
Acorda Site #146
Lexington, Kentucky, United States
Acorda Site #150
New Orleans, Louisiana, United States
Acorda Site #175
Fulton, Maryland, United States
Acorda Site #136
Boston, Massachusetts, United States
Acorda Site #121
Boston, Massachusetts, United States
Acorda Site #123
East Lansing, Michigan, United States
Acorda Site #164
Farmington Hills, Michigan, United States
Acorda Site #159
Grand Rapids, Michigan, United States
Acorda Site #101
Kansas City, Missouri, United States
Acorda Site #111
Great Falls, Montana, United States
Acorda Site #140
Reno, Nevada, United States
Acorda Site #131
New Brunswick, New Jersey, United States
Acorda Site #177
Stratford, New Jersey, United States
Acorda Site #172
New York, New York, United States
Acorda Site #179
Patchogue, New York, United States
Acorda Site #114
White Plains, New York, United States
Acorda Site #166
Chapel Hill, North Carolina, United States
Acorda Site #167
Durham, North Carolina, United States
Acorda Site #162
Mooresville, North Carolina, United States
Acorda Site #154
Raleigh, North Carolina, United States
Acorda Site #132
Winston-Salem, North Carolina, United States
Acorda Site #137
Columbus, Ohio, United States
Acorda Site #116
Dayton, Ohio, United States
Acorda Site #152
Corvallis, Oregon, United States
Acorda Site #168
Portland, Oregon, United States
Acorda Site #126
Portland, Oregon, United States
Acorda Site #122
Philadelphia, Pennsylvania, United States
Acorda Site #144
Providence, Rhode Island, United States
Acorda Site #157
Memphis, Tennessee, United States
Acorda Site #113
Dallas, Texas, United States
Acorda Site #165
Dallas, Texas, United States
Acorda Site #108
Houston, Texas, United States
Acorda Site #182
Falls Church, Virginia, United States
Acorda Site #176
Richmond, Virginia, United States
Acorda Site #107
Spokane, Washington, United States
Acorda Site #203
Fredericton, New Brunswick, Canada
Acorda Site #202
Halifax, Nova Scotia, Canada
Acorda Site #201
Greenfield Park, Quebec, Canada
Acorda Site #204
Montreal, Quebec, Canada
Countries
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Other Identifiers
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DALF-PS-1029
Identifier Type: -
Identifier Source: org_study_id
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