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 in Subjects Who Participated in the DALF-PS-1016 Study

Description

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.

Study Start Date

April 2015

Estimated Completion Date

November 2017

Interventions

  • Drug: dalfampridine-ER 10 mg
  • Drug: dalfampridine-ER 7.5 mg

Specialties

  • Cardiology: Vascular Medicine
  • Neurology: Stroke/Vascular
  • Physician Assistant: Cardiology,Neurology

MeSH Terms

  • Stroke

Study ID

Acorda Therapeutics -- DALF-PS-1029

Status

Unknown

Trial ID

NCT02422940

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

100

Sponsor

Acorda Therapeutics

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (27)

Study Location Distance Name Phone Email
Acorda Site 149 - Fairfield, Connecticut 4.0 miles Micah Sy 203-333-1151 None
Acorda Site 110 - Danbury, Connecticut 16.1 miles Dawn Morsey 203-748-2551 None
Acorda Site 130 - Stamford, Connecticut 17.9 miles Grace Valentin 203-914-1903 None
Acorda Site 114 - White Plains, New York 29.7 miles Sharon Singh 914-597-2308 None
Acorda Site 131 - New Brunswick, New Jersey 80.6 miles Michelle Moccio 732-235-8582 None
Acorda Site 122 - Philadelphia, Pennsylvania 134.5 miles Nichole Gallatti 215-349-8651 None
Acorda Site 121 - Boston, Massachusetts 137.1 miles Helena Lau 617-414-1171 None
Acorda Site 136 - Boston, Massachusetts 137.9 miles Thomas Wickham 617-724-0960 None
Acorda Site 132 - Winston-Salem, North Carolina 523.2 miles Ashley Morton 336-608-3070 None
Acorda Site 162 - Mooresville, North Carolina 565.9 miles Carri Faircloth 704-235-1834 None
Acorda Site 146 - Lexington, Kentucky 644.1 miles Judy Kinley 859-685-0663 None
Acorda Site 156 - Franklin, Indiana 685.7 miles Christine Bogardus 317-738-7448 None
Acorda Site 148 - Avon, Indiana 718.8 miles Judy Smith 317-745-8000 None
Acorda Site 115 - Atlantis, Florida 1,086.6 miles Janette Bossaers 561-968-2933 None
Acorda Site 101 - Kansas City, Missouri 1,136.0 miles Pamela McCann 816-276-3890 None
Acorda Site 128 - Hialeah, Florida 1,137.7 miles Raydel de la Morena 305-827-3335 None
Acorda Site 103 - Miami, Florida 1,140.0 miles Iridalia Gonzalez 786-378-8200 None
Acorda Site 133 - Miami, Florida 1,148.7 miles Reisy Guedes 305-226-3933 None
Acorda Site 113 - Dallas, Texas 1,417.7 miles Todd Morgan 214-827-3610 None
Acorda Site 124 - Colorado Springs, Colorado 1,672.5 miles Jodi Ventimiglia 719-473-3272 None
Acorda Site 111 - Great Falls, Montana 1,911.9 miles Laura Armstrong 406-455-2583 None
Acorda Site 117 - Gilbert, Arizona 2,171.5 miles Leslie Munson 480-610-0177 None
Acorda Site 140 - Reno, Nevada 2,428.7 miles Peggie Smith 775-982-2949 None
Acorda Site 142 - Pasadena, California 2,482.6 miles Donna Sider 626-356-0800 None
Acorda Site 105 - Newport Beach, California 2,485.6 miles Laura Whitaker 949-764-8190 None
Acorda Site 138 - Long Beach, California 2,493.3 miles Agyn Atienza 866-787-4257 None
Acorda Site 152 - Corvallis, Oregon 2,508.9 miles Kimberly Tally 541-754-1398 None

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