Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Fampridine-SR

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia, Vancouver Coastal Health Research Institute
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 0C7
      • River Valley Health c/o Stan Cassidy Centre for Rehabilitation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Neurological Associates
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates Summit Medical Center - Research and Education Institute
    • Los Angeles, California, United States, 90033
      • USC, Keck School of Medicine Health Care Consultation Center
    • Sacramento, California, United States, 95817
      • UC Davis
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University MS Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University MS Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Associates in Neurology, PSC
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Maryland Center for MS
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Lahey Clinic
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University, Department of Neurology
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • The Schapiro Center for MS
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Great Falls, Montana, United States, 59405
      • Advanced Neurology Specialists
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • UMDNJ
    • Teaneck, New Jersey, United States, 07666
      • Gimbel MS Center at Holy Name Hospital
  • New York
    • Buffalo, New York, United States, 14203
      • Jacobs Neurological Institute Buffalo General Hospital
    • New York, New York, United States, 10029
      • Corinne Goldsmith Dickinson Center for MS
    • New York, New York, United States, 10032
      • Columbia University Multiple Sclerosis Clinical Care Center
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • CMC - Neuroscience & Spine Institute, Division of Neurology
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University, Dept of Neurology, M.S. Research
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • The Center for Neurological Services
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43221
      • Ohio State University MS Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University, MS Center of Oregon, UHS-42
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Physicians
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Neurological Research Center, Inc.
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center at Evergreen
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education & Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Center for Neurological Disorders of Aurora, St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo
• Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: 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)
• Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator
• Patient must be of adequate cognitive function, as judged by the Investigator
• Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit

Exclusion Criteria:

• Female patients who are either pregnant or breastfeeding.
• Women of childbearing potential who are not using a specified birth control method
• Patients discontinued prematurely from the MS-F204 study
• Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG
• Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit
• Patient with severe renal impairment
• Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
• Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet
• Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
• Patient who has a history of drug or alcohol abuse within the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Treatment Emergent Adverse Events (TEAE).	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.	up to 40 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed 25-Foot Walk (T25FW)		Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Subject Global Impression (SGI)	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.	Visit 1 and every clinic visit thereafter (other than the follow-up visit)
Clinician's Global Impression (CGI)	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.	Visit 1 and every clinic visit thereafter
Expanded Disability Status Scale (EDSS)	The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)	The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Investigators: Study Director: Bonnie Faust, Acorda Therapeutics

Publications and helpful links

Helpful Links

• Click here for more information about Fampridine-SR clinical trials

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: MS; multiple sclerosis; walking; leg strength; demyelination
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: MS-F204 EXT