Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis

NCT ID: NCT01328379

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-07-31

Brief 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.

Detailed Description

The current study is designed as a prospective placebo-controlled trial to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in MS patients during a four-week period of treatment.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dalfampridine-ER 5mg

5mg, twice daily

Group Type: ACTIVE_COMPARATOR

Dalfampridine-ER 5mg

Intervention Type: DRUG

5mg, twice daily

Dalfampridine-ER 10mg

10mg, twice daily

Group Type: ACTIVE_COMPARATOR

Dalfampridine-ER 10mg

Intervention Type: DRUG

10mg, twice daily

Placebo

placebo, twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo, twice daily

Interventions

Dalfampridine-ER 5mg

5mg, twice daily

Intervention Type: DRUG

Dalfampridine-ER 10mg

10mg, twice daily

Intervention Type: DRUG

Placebo

placebo, twice daily

Intervention Type: OTHER

Other Intervention Names

Fampridine, Dalfampridine, Ampyra; Fampridine, Dalfampridine, Ampyra

Eligibility Criteria

Inclusion Criteria

• Patient has clinically definite Multiple Sclerosis as defined by the MacDonald Criteria.
• Patient must be 18 to 70 years of age, inclusive (i.e. on or after their 18th birthday, up to the day before their 71st birthday at the Screening Visit).
• Patient who has previously taken Ampyra® or dalfampridine (fampridine or 4 aminopyridine; 4-AP) in any formulation (including compounded), must have withdrawn from the drug for at least one month prior to the Screening Visit.
• Patient must be mentally competent to understand and sign the Internal Review Board (IRB)-approved informed consent prior to the performance of any study-specific procedures.
• Patient is able to perform all the required study procedures.
• In the judgement of the Investigator, the patient has MS-related walking impairment but has sufficient ambulatory ability to be able to complete two trials of the Timed 25 Foot Walk (T25FW) at the screening Visit and every study visit thereafter, with the two trials completed within 5 minutes of one another and in accordance with the specific instructions provided by the National Multiple Sclerosis Society MS Functional Composite Manual.
• Patient who is female and of childbearing potential (see Exclusion Criterion 1 for definition) must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria

• Patient is a female of childbearing potential (i.e., has not had a hysterectomy or bilateral oophorectomy, or is not at least two years postmenopausal), engaged in active heterosexual relations and is not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch or injectable contraceptive, double barrier method, or sexual activity restricted to vasectomized partner.
• Patient is pregnant or breastfeeding.
• Patient has any history of seizures.
• Patient has moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute.
• Patient has active urinary tract infection (UTI) at Screening or within the 4 weeks before Screening.
• Patient has had an onset (as assessed by the treating physician) of an MS exacerbation within 60 days prior to the Screening Visit.
• Patient has started on a concomitant prescription medication regimen within the last three weeks, and/or their concomitant medication regimen is expected to change during the course of the study.
• Patient has received cyclophosphamide (Cytoxan) or mitoxantrone (Novantrone) for MS treatment within six months prior to the Screening Visit.
• Patient has started a treatment regimen of Betaseron, Avonex, Copaxone, Rebif, Tysabri, Extavia or Gilenya™ within 90 days prior to the Screening Visit or has had any change in the dosing regimen of these drugs within 30 days prior to the Screening Visit.
• Patient has received corticosteroids (other than topical preparations) within 30 days prior to the Screening Visit and/or is expected to receive regularly scheduled corticosteroid treatment during the course of the study.
• Patient has been administered botulinum toxin in the lower extremities within six months prior to the Screening Visit and/or is expected to receive botulinum toxin in the lower extremities during the course of the study.
• Patient has a known allergy to pyridine-containing substances or any of the inactive ingredients of the dalfampridine tablet (colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide).
• Patient has a history of drug or alcohol abuse within the past year.
• Patient has clinically significant abnormal laboratory values.
• Patient has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality.
• Patient has any medical condition (including psychiatric disease)that would interfere with the interpretation of the study results or the conduct of the study.
• Patient has participated in an investigational trial 30 days prior to Screening Visit or plans to enroll in another investigational trial at any time during this study. Non-drug (i.e. observational, registry) and non- medical device trials are allowed.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew R. Blight, PhD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Mark Agius, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Angela Applebee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

S. A Azizi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University Hospital

Francois Bethoux, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Christopher Bever, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Maryland Center for Multiple Sclerosis

Eric Borresen, MD

Role: PRINCIPAL_INVESTIGATOR

Metrolina Medical Research

Aaron Boster, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University, Columbus

Ann Camac, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic

Mark Cascione, MD

Role: PRINCIPAL_INVESTIGATOR

Axiom Clinical Research of Florida

Jane Chan, MD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Warren Chumley, MD

Role: PRINCIPAL_INVESTIGATOR

Associates in Neurology, PSC

Joanna Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Alta Bates Summit Medical Center

Joy Derwenskus, DO

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Adam DiDio, MD

Role: PRINCIPAL_INVESTIGATOR

Suncoast Neuroscience Associates, Inc.

Dennis Dietrich, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Neurology Specialists

Geoffery Eubank, MD

Role: PRINCIPAL_INVESTIGATOR

Neurological Research Institute

Steven Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

Raleigh Neurology Associates

Daniel Giang, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Lawrence Goldstick, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Specialists, Inc.

Andrew Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Mark Gudesblatt, MD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

Barry Hendin, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Neurological Associates, LTD

Craig Herrman, MD

Role: PRINCIPAL_INVESTIGATOR

Josephson Wallack Munshower Neurology, PC

William Honeycutt, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Associates, PA

Bruce Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Ruan Neurology Clinical Research Center

Samuel Hunter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Advanced Neurosciences Institute

George Hutton, MD

Role: PRINCIPAL_INVESTIGATOR

Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine

Dina Jacobs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Todd Janus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa Health Des Moines

Omar Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Bhupendra Khatri, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Saint Luke's Medical Center

Kiren Kresa-Reahl, MD

Role: PRINCIPAL_INVESTIGATOR

Charleston Area Medical Center Health Education and Research Institute, Inc.

Christopher LaGanke, MD

Role: PRINCIPAL_INVESTIGATOR

North Central Neurology Associates, PC

Sharon Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Michele Mass, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

David Mattson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Angeli Mayadev, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Neuroscience Institute

Donald Negroski, MD

Role: PRINCIPAL_INVESTIGATOR

Negroski, Stein, Sutherland and Hanes Neurology

Stephen Newman, MD

Role: PRINCIPAL_INVESTIGATOR

Island Neurological Associates, PC

Gabriel Pardo, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Multiple Sclerosis Center of Oklahoma Mercy Neuroscience Institute

C. Fish Greenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Neurology, PA

Rekha Pillai, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Clinic, PC

T. Hemanth Rao, MD

Role: PRINCIPAL_INVESTIGATOR

The Neurological Institute, PA

Syed Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Matthew Roller, MD

Role: PRINCIPAL_INVESTIGATOR

Altru Health System Research Center

Michael Rossen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Springfield Neurology Associates, LLC

Alan Schulman, MD

Role: PRINCIPAL_INVESTIGATOR

Neurological Associates

James S Shafer, MD

Role: PRINCIPAL_INVESTIGATOR

The Multiple Sclerosis Center of Vero Beach

Jatin Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Neurological Institute

William Sheremata, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami School of Medicine, Dept. of Neurology

Brian Steingo, MD

Role: PRINCIPAL_INVESTIGATOR

Neurological Associates

James Storey, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Upstate Clinical Research, LLC

Ben Thrower, MD

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Inc.

Carlo Tornatore, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

K A Lloyd, MD

Role: PRINCIPAL_INVESTIGATOR

Hampton Roads Neurology

Anthony Turel, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University, Milton S. Hershey Medical Center

Sibyl E Wray, MD

Role: PRINCIPAL_INVESTIGATOR

Sibyl E. Wray, MD, Neurology, PC

Daniel Wynn, MD

Role: PRINCIPAL_INVESTIGATOR

Consultants in Neurology Ltd.

Robert Yapundich, MD

Role: PRINCIPAL_INVESTIGATOR

Unifour Medical Research, LLC

Locations

North Central Neurology Associates, PC

Cullman, Alabama, United States

Phoenix Neurological Associates, Ltd

Phoenix, Arizona, United States

Arizona Neurological Institute

Sun City, Arizona, United States

Clinical Research Advantage Inc.

Tempe, Arizona, United States

Sutter East Bay Physicians Medical Foundation

Berkeley, California, United States

Neuro-Pain Medical Center, Inc.

Fresno, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Collaborative NeuroScience Network, Inc.

Long Beach, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Neurology Associates, PA

Maitland, Florida, United States

University of Miami School of Medicine, Dept. of Neurology

Miami, Florida, United States

Neurological Associates

Pompano Beach, Florida, United States

Neurologique Foundation, Inc.

Ponte Vedra, Florida, United States

Negroski, Sutherland and Hanes Neurology

Sarasota, Florida, United States

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Tallahassee Neurological Clinic, PA

Tallahassee, Florida, United States

Axiom Clinical Research of Florida

Tampa, Florida, United States

The Multiple Sclerosis Center of Vero Beach

Vero Beach, Florida, United States

Sheperd Center, Inc.

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Consultants in Neurology Ltd.

Northbrook, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

Methodist Plaza Specialty

Des Moines, Iowa, United States

Ruan Neurology Clinic and Research Center

Des Moines, Iowa, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Associates in Neurology, PSC

Lexington, Kentucky, United States

University of Maryland, Maryland Center for Multiple Sclerosis

Baltimore, Maryland, United States

Lahey Clinic

Lexington, Massachusetts, United States

Springfield Neurology Associates, LLC

Springfield, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Advanced Neurology Specialists

Great Falls, Montana, United States

Veterans Administration Sierra Neveda Health Care System

Reno, Nevada, United States

Upstate Clinical Research, LLC

Albany, New York, United States

NYU Langone Medical Center MS Comprehensive Care Center

New York, New York, United States

Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates

Patchogue, New York, United States

Island Neurological Associates, PC

Plainview, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

PMG Research of Charlotte

Charlotte, North Carolina, United States

The Neurological Institute, PA

Charlotte, North Carolina, United States

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

Raleigh Neurology Associates

Raleigh, North Carolina, United States

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Altru Health System Clinic

Grand Forks, North Dakota, United States

Northern Ohio Neuroscience, LLC

Bellevue, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Neurological Research Institute

Columbus, Ohio, United States

Ohio State University, Columbus

Columbus, Ohio, United States

Neurology Specialists, Inc.

Dayton, Ohio, United States

OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Providence Multiple Sclerosis Center

Portland, Oregon, United States

The Pennsylvania State University, Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

The Neurology Foundation, Inc.

Providence, Rhode Island, United States

Wesley Neurology Clinic, PC

Cordova, Tennessee, United States

Advanced Neurosciences Institute

Franklin, Tennessee, United States

Sibyl E. Wray, MD, Neurology, PC

Knoxville, Tennessee, United States

Texas Neurology, PA

Dallas, Texas, United States

Kelsey-Seybold Clinic

Houston, Texas, United States

Maxine Mesinger Multiple Sclerosis Clinic; Baylor College of Medicine

Houston, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Hampton Roads Neurology

Newport News, Virginia, United States

Neurological Associates

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Applebee A, Goodman AD, Mayadev AS, Bethoux F, Goldman MD, Klingler M, Blight AR, Carrazana EJ. Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial. Clin Ther. 2015 Dec 1;37(12):2780-7. doi: 10.1016/j.clinthera.2015.10.014. Epub 2015 Nov 10.

Reference Type: DERIVED

PMID: 26565077 (View on PubMed)

Kantor D, Chancellor MB, Snell CW, Henney HR 3rd, Rabinowicz AL. Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis. Postgrad Med. 2015 Mar;127(2):218-22. doi: 10.1080/00325481.2015.1000229. Epub 2015 Jan 6.

Reference Type: DERIVED

PMID: 25560174 (View on PubMed)

Other Identifiers

DER-401

Identifier Type: -

Identifier Source: org_study_id