Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

Summary

The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.

Conditions

• Multiple Sclerosis

Interventions

DRUG

Dalfampridine-ER 5mg

5mg, twice daily

DRUG

Dalfampridine-ER 10mg

10mg, twice daily

OTHER

Placebo

placebo, twice daily

Sponsors & Collaborators

• Acorda Therapeutics

  lead INDUSTRY

Principal Investigators

• Andrew R. Blight, PhD · Acorda Therapeutics

• Mark Agius, MD · University of California, Davis

• Angela Applebee, MD · University of Vermont Medical Center

• S. A Azizi, MD, PhD · Temple University Hospital

• Francois Bethoux, MD · The Cleveland Clinic

• Christopher Bever, Jr., MD · University of Maryland, Maryland Center for Multiple Sclerosis

• Eric Borresen, MD · Metrolina Medical Research

• Aaron Boster, MD · Ohio State University, Columbus

• Ann Camac, MD · Lahey Clinic

• Mark Cascione, MD · Axiom Clinical Research of Florida

• Jane Chan, MD · US Department of Veterans Affairs

• Warren Chumley, MD · Associates in Neurology, PSC

• Joanna Cooper, MD · Alta Bates Summit Medical Center

• Joy Derwenskus, DO · Northwestern University

• Adam DiDio, MD · Suncoast Neuroscience Associates, Inc.

• Dennis Dietrich, MD · Advanced Neurology Specialists

• Geoffery Eubank, MD · Neurological Research Institute

• Steven Freedman, MD · Raleigh Neurology Associates

• Daniel Giang, MD · Loma Linda University Medical Center

• Lawrence Goldstick, MD · Neurology Specialists, Inc.

• Andrew Goodman, MD · University of Rochester

• Mark Gudesblatt, MD · Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

• Barry Hendin, MD · Phoenix Neurological Associates, LTD

• Craig Herrman, MD · Josephson Wallack Munshower Neurology, PC

• William Honeycutt, MD · Neurology Associates, PA

• Bruce Hughes, MD · Ruan Neurology Clinical Research Center

• Samuel Hunter, MD, PhD · Advanced Neurosciences Institute

• George Hutton, MD · Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine

• Dina Jacobs, MD · University of Pennsylvania

• Todd Janus, MD, PhD · Iowa Health Des Moines

• Omar Khan, MD · Wayne State University

• Bhupendra Khatri, MD · Aurora Saint Luke's Medical Center

• Kiren Kresa-Reahl, MD · Charleston Area Medical Center Health Education and Research Institute, Inc.

• Christopher LaGanke, MD · North Central Neurology Associates, PC

• Sharon Lynch, MD · University of Kansas Medical Center

• Michele Mass, MD · Oregon Health and Science University

• David Mattson, MD, PhD · Indiana University

• Angeli Mayadev, MD · Swedish Neuroscience Institute

• Donald Negroski, MD · Negroski, Stein, Sutherland and Hanes Neurology

• Stephen Newman, MD · Island Neurological Associates, PC

• Gabriel Pardo, MD · Mercy Multiple Sclerosis Center of Oklahoma Mercy Neuroscience Institute

• C. Fish Greenfield, MD · Texas Neurology, PA

• Rekha Pillai, MD · Neurology Clinic, PC

• T. Hemanth Rao, MD · The Neurological Institute, PA

• Syed Rizvi, MD · Rhode Island Hospital

• Matthew Roller, MD · Altru Health System Research Center

• Michael Rossen, MD, PhD · Springfield Neurology Associates, LLC

• Alan Schulman, MD · Neurological Associates

• James S Shafer, MD · The Multiple Sclerosis Center of Vero Beach

• Jatin Shah, MD · Arizona Neurological Institute

• William Sheremata, MD · University of Miami School of Medicine, Dept. of Neurology

• Brian Steingo, MD · Neurological Associates

• James Storey, Jr, MD · Upstate Clinical Research, LLC

• Ben Thrower, MD · Shepherd Center, Inc.

• Carlo Tornatore, MD · Georgetown University Hospital

• K A Lloyd, MD · Hampton Roads Neurology

• Anthony Turel, Jr, MD · The Pennsylvania State University, Milton S. Hershey Medical Center

• Sibyl E Wray, MD · Sibyl E. Wray, MD, Neurology, PC

• Daniel Wynn, MD · Consultants in Neurology Ltd.

• Robert Yapundich, MD · Unifour Medical Research, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2012-04-30

Completion

2012-07-31

Countries

• United States

Study Locations