Clinical trial NCT00648908: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
MS
walking
leg strength
demyelination
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Summary of Treatment Emergent Adverse Events (TEAE).
timeFrame: up to 5 years
Secondary outcomes:
measure: Timed 25 Foot Walk (T25FW)
timeFrame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit
measure: Subject Global Impression (SGI)
timeFrame: visit 1 and every clinic visit
measure: Clinician Global Impression of Change (CGIC)
timeFrame: visit 1 and every clinic visit
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Screening visit, visit 6 and every 24 months thereafter
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: USC, Keck School of Medicine Health Care Consultation Center
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University MS Center
state: Indiana
city: Baltimore
country: United States
facility: Maryland Center for MS
state: Maryland
city: Detroit
country: United States
facility: Wayne State University, Department of Neurology
state: Michigan
city: Golden Valley
country: United States
facility: The Schapiro Center for MS
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine, Div. of Rehab/Neurology
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Teaneck
country: United States
facility: Gimbel MS Center at Holy Name Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides MS Care Center
state: New York
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for MS
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Charlotte
country: United States
facility: CMC - Neuroscience & Spine Institute, Division of Neurology
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University MS Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University, MS Center of Oregon, UHS-42
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Physicians
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital, Allegheny Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Bennington
country: United States
facility: Neurological Research Center, Inc.
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Kirkland
country: United States
facility: MS Center at Evergreen
state: Washington
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia, Vancouver Coastal Health Research Institute
state: British Columbia
city: Fredericton
country: Canada
facility: River Valley Health c/o Stan Cassidy Centre for Rehabilitation
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Acorda Therapeutics
name: Bonnie Faust
role: STUDY_DIRECTOR
References: