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
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
1 other identifier
interventional
269
2 countries
32
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.
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 Jun 2006
Typical duration for phase_3 multiple-sclerosis
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
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 27, 2012
January 1, 2012
4.6 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 5 years
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
Clinician Global Impression of Change (CGIC)
visit 1 and every clinic visit
Expanded Disability Status Scale (EDSS)
Screening visit, visit 6 and every 24 months thereafter
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, 90033, United States
UC Davis
Sacramento, California, 95817, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University MS Center
Indianapolis, Indiana, 46202, United States
Maryland Center for MS
Baltimore, Maryland, 21201, 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, Div. of Rehab/Neurology
St Louis, Missouri, 63110, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Maimonides MS Care Center
Brooklyn, New York, 11219, United States
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029, 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
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
Allegheny General Hospital, Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212, United States
University of Texas-Houston
Houston, Texas, 77030, 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
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
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6, 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
June 1, 2006
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
February 27, 2012
Results First Posted
February 27, 2012
Record last verified: 2012-01