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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
269
Tablets, 10 mg, BID
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.
Time frame: up to 5 years
Timed 25 Foot Walk (T25FW)
Time frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Subject Global Impression (SGI)
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.
Time frame: visit 1 and every clinic visit
Clinician Global Impression of Change (CGIC)
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.
Time frame: visit 1 and every clinic visit
Expanded Disability Status Scale (EDSS)
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.
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Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
Shepherd Center
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University MS Center
Indianapolis, Indiana, United States
Maryland Center for MS
Baltimore, Maryland, United States
Wayne State University, Department of Neurology
Detroit, Michigan, United States
The Schapiro Center for MS
Golden Valley, Minnesota, United States
Washington University School of Medicine, Div. of Rehab/Neurology
St Louis, Missouri, United States
...and 22 more locations
Time frame: Screening visit, visit 6 and every 24 months thereafter