Clinical trial NCT00649792: 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
Official title: 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
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: 214
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 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.

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:

* 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

Primary outcomes:
measure: Summary of Treatment Emergent Adverse Events (TEAE).
timeFrame: up to 40 months
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 thereafter (other than the follow-up visit)
measure: Clinician's Global Impression (CGI)
timeFrame: Visit 1 and every clinic visit thereafter
measure: Expanded Disability Status Scale (EDSS)
timeFrame: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Fayetteville
country: United States
facility: Neurological Associates
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center - Research and Education Institute
state: California
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: New Haven
country: United States
facility: Yale University MS Center
state: Connecticut
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University MS Center
state: Indiana
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Center for MS
state: Maryland
city: Lexington
country: United States
facility: Lahey Clinic
state: Massachusetts
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
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Teaneck
country: United States
facility: Gimbel MS Center at Holy Name Hospital
state: New Jersey
city: Buffalo
country: United States
facility: Jacobs Neurological Institute Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for MS
state: New York
city: New York
country: United States
facility: Columbia University Multiple Sclerosis Clinical Care Center
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: Winston-Salem
country: United States
facility: Wake Forest University, Dept of Neurology, M.S. Research
state: North Carolina
city: Bismarck
country: United States
facility: The Center for Neurological Services
state: North Dakota
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: 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: Charleston
country: United States
facility: CAMC Health Education & Research Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Center for Neurological Disorders of Aurora, St. Luke's Medical Center
state: Wisconsin
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
Study officials:
affiliation: Acorda Therapeutics
name: Bonnie Faust
role: STUDY_DIRECTOR
References: