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

Multiple Sclerosis Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649792
• Other study ID #: MS-F204 EXT
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: February 24, 2012
• Start date: August 2007
• Est. completion date: April 2011

Study information

• Verified date: January 2012
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampridine-SR
Tablets, 10 mg, BID (twice daily)

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	River Valley Health c/o Stan Cassidy Centre for Rehabilitation	Fredericton	New Brunswick
Canada	QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site	Halifax	Nova Scotia
Canada	University of British Columbia, Vancouver Coastal Health Research Institute	Vancouver	British Columbia
United States	Shepherd Center	Atlanta	Georgia
United States	Maryland Center for MS	Baltimore	Maryland
United States	Neurological Research Center, Inc.	Bennington	Vermont
United States	Alta Bates Summit Medical Center - Research and Education Institute	Berkeley	California
United States	The Center for Neurological Services	Bismarck	North Dakota
United States	Jacobs Neurological Institute Buffalo General Hospital	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	CAMC Health Education & Research Institute	Charleston	West Virginia
United States	CMC - Neuroscience & Spine Institute, Division of Neurology	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University MS Center	Columbus	Ohio
United States	Wayne State University, Department of Neurology	Detroit	Michigan
United States	Neurological Associates	Fayetteville	Arkansas
United States	The Schapiro Center for MS	Golden Valley	Minnesota
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Indiana University MS Center	Indianapolis	Indiana
United States	MS Center at Evergreen	Kirkland	Washington
United States	Associates in Neurology, PSC	Lexington	Kentucky
United States	Lahey Clinic	Lexington	Massachusetts
United States	USC, Keck School of Medicine Health Care Consultation Center	Los Angeles	California
United States	Center for Neurological Disorders of Aurora, St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Yale University MS Center	New Haven	Connecticut
United States	Columbia University Multiple Sclerosis Clinical Care Center	New York	New York
United States	Corinne Goldsmith Dickinson Center for MS	New York	New York
United States	UMDNJ	Newark	New Jersey
United States	Consultants in Neurology, Ltd.	Northbrook	Illinois
United States	Thomas Jefferson University Physicians	Philadelphia	Pennsylvania
United States	Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	Oregon Health & Science University, MS Center of Oregon, UHS-42	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	University of Rochester	Rochester	New York
United States	UC Davis	Sacramento	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	SUNY Stony Brook	Stony Brook	New York
United States	Gimbel MS Center at Holy Name Hospital	Teaneck	New Jersey
United States	Wake Forest University, Dept of Neurology, M.S. Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Timed 25-Foot Walk (T25FW)		Week 2, 14, 26, continuing every 26 weeks until the Final Visit	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No

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