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
1 other identifier
interventional
214
2 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-sclerosis
Started Aug 2007
Typical duration for phase_3 multiple-sclerosis
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
February 27, 2012
CompletedFebruary 28, 2012
January 1, 2012
3.4 years
March 28, 2008
January 25, 2012
February 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Timed 25-Foot Walk (T25FW)
Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Subject Global Impression (SGI)
Visit 1 and every clinic visit thereafter (other than the follow-up visit)
Clinician's Global Impression (CGI)
Visit 1 and every clinic visit thereafter
Expanded Disability Status Scale (EDSS)
The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Neurological Associates
Fayetteville, Arkansas, 72703, United States
Alta Bates Summit Medical Center - Research and Education Institute
Berkeley, California, 94705, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, 90033, United States
UC Davis
Sacramento, California, 95817, United States
Yale University MS Center
New Haven, Connecticut, 06510, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Indiana University MS Center
Indianapolis, Indiana, 46202, United States
Associates in Neurology, PSC
Lexington, Kentucky, 40503, United States
Maryland Center for MS
Baltimore, Maryland, 21201, United States
Lahey Clinic
Lexington, Massachusetts, 02421, United States
Wayne State University, Department of Neurology
Detroit, Michigan, 48201, United States
The Schapiro Center for MS
Golden Valley, Minnesota, 55422, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
UMDNJ
Newark, New Jersey, 07103, United States
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Jacobs Neurological Institute Buffalo General Hospital
Buffalo, New York, 14203, United States
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029, United States
Columbia University Multiple Sclerosis Clinical Care Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte, North Carolina, 28207, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wake Forest University, Dept of Neurology, M.S. Research
Winston-Salem, North Carolina, 27157, United States
The Center for Neurological Services
Bismarck, North Dakota, 58501, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University MS Center
Columbus, Ohio, 43221, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, 97239, United States
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, 19107, United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
MS Center at Evergreen
Kirkland, Washington, 98034, United States
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304, United States
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V6T 2B5, Canada
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7, Canada
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, B3H 4K4, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Blight, PhD Chief Scientific Officer
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Bonnie Faust
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
August 1, 2007
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
February 28, 2012
Results First Posted
February 27, 2012
Record last verified: 2012-01