Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT00648908
First received: March 28, 2008
Last updated: February 24, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.


Condition Intervention Phase
Multiple Sclerosis
Drug: Fampridine-SR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.


Secondary Outcome Measures:
  • Timed 25 Foot Walk (T25FW) [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]

    Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).

    For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.


  • Clinician Global Impression of Change (CGIC) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]

    Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.

    The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.


  • Expanded Disability Status Scale (EDSS) [ Time Frame: Screening visit, visit 6 and every 24 months thereafter ] [ Designated as safety issue: No ]

    Each patient, based on their baseline neurological exam, are scored according to the EDSS

    The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable.



Enrollment: 269
Study Start Date: June 2006
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fampridine-SR
    Tablets, 10 mg, BID
    Other Name: 4-aminopyridine
Detailed Description:

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo
  • subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis; Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals of Neurology. 2001; 50: 121-127)
  • subject must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator
  • subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol
  • subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria:

  • women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
  • subject discontinued prematurely from the MS-F203 study
  • subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG
  • subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study
  • subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
  • subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))
  • subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study.
  • subject has a history of drug or alcohol abuse within the past year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648908

  Hide Study Locations
Locations
United States, Arizona
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, United States, 90033
UC Davis
Sacramento, California, United States, 95817
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University MS Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Maryland Center for MS
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University, Department of Neurology
Detroit, Michigan, United States, 48201
United States, Minnesota
The Schapiro Center for MS
Golden Valley, Minnesota, United States, 55422
United States, Missouri
Washington University School of Medicine, Div. of Rehab/Neurology
St. Louis, Missouri, United States, 63110
United States, Montana
Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
United States, New Jersey
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, New York
Maimonides MS Care Center
Brooklyn, New York, United States, 11219
Corinne Goldsmith Dickinson Center for MS
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14642
SUNY Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte, North Carolina, United States, 28207
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University MS Center
Columbus, Ohio, United States, 43221
United States, Oregon
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital, Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
University of Texas-Houston
Houston, Texas, United States, 77030
United States, Vermont
Neurological Research Center, Inc.
Bennington, Vermont, United States, 05201
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
MS Center at Evergreen
Kirkland, Washington, United States, 98034
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V6T 2B5
Canada, New Brunswick
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, Canada, E3B 0C7
Canada, Nova Scotia
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Bonnie Faust Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00648908     History of Changes
Other Study ID Numbers: MS-F203EXT
Study First Received: March 28, 2008
Results First Received: January 25, 2012
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Acorda Therapeutics:
multiple sclerosis
MS
walking
leg strength
demyelination

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014