Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.



Status:Terminated
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:April 2015
End Date:January 2017

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An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of
two dose strengths of dalfampridine-ER.

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of
two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12
months to subjects with chronic post-ischemic stroke walking deficits who have completed the
controlled, double-blind Study DALF-PS-1016.

Key Inclusion Criteria:

- Completion of the DALF-PS-1016 study

- 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

Key Exclusion Criteria:

- Seizures, new onset strokes (or other significant neurological event precluding
long-term continuation) occurring during the antecedent DALF-PS-1016 study

- Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the
long-term extension study
We found this trial at
60
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Great Falls, Montana 59405
Phone: 406-455-2583
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Atlantis, Florida 33462
Phone: 561-968-2933
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Avon, Indiana 46123
Phone: 317-745-8000
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Berkeley, California 94705
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Boston, Massachusetts 02118
Phone: 617-414-1171
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Boston, Massachusetts 02118
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Carlsbad, California 92011
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Chapel Hill, North Carolina 27599
Phone: 919-962-5137
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Chicago, Illinois 60612
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Colorado Springs, Colorado 80907
Phone: 719-473-3272
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Columbus, Ohio 43210
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Corvallis, Oregon 97330
Phone: 541-754-1398
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Dallas, Texas 75214
Phone: 214-827-3610
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Danbury, Connecticut 06810
Phone: 203-748-2551
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Dayton, Ohio 45417
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Deerfield Beach, Florida 33064
Phone: 954-786-6736
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Durham, North Carolina 27705
Phone: 919-684-0071
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East Lansing, Michigan 48824
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Fairfield, Connecticut 06824
Phone: 203-333-1151
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Falls Church, Virginia 22043
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Farmington Hills, Michigan 48334
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Fort Wayne, Indiana 46804
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Franklin, Indiana 46131
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Fredericton, New Brunswick
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Fulton, Maryland 20759
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Gainesville, Florida 32607
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Gilbert, Arizona 85234
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Grand Rapids, Michigan 49503
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Hialeah, Florida 33012
Phone: 305-827-3335
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Honolulu, Hawaii 96734
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Houston, Texas 77030
Phone: 713-441-5801
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Jacksonville, Florida 32209
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Kansas City, Missouri 64132
Phone: 816-651-8518
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Lexington, Kentucky 40513
Phone: 859-685-0663
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Long Beach, California 90806
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Memphis, Tennessee 38163
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Miami, Florida 33142
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Miami, Florida 33142
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Mooresville, North Carolina 28117
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Naples, Florida 34102
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New Brunswick, New Jersey 08901
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New Orleans, Louisiana 70121
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New York, New York 10016
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Newport Beach, California 92663
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Pasadena, California 91105
Phone: 626-356-0800
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Patchogue, New York 11772
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Philadelphia, Pennsylvania 19107
Phone: 215-349-8651
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Portland, Oregon 97239
Phone: 503-494-8001
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Providence, Rhode Island 02903
Phone: 401-444-9264
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Raleigh, North Carolina 27607
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Reno, Nevada 89502
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Richmond, Virginia 23298
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Sacramento, California 95823
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San Diego, California 92103
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Spokane, Washington 99202
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Stamford, Connecticut 06905
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Stratford, New Jersey 08084
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Tampa, Florida 33613
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White Plains, New York 10605
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Winston-Salem, North Carolina 27103
Phone: 336-608-3070
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