- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Center
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2B5
- University of British Columbia, Vancouver Coastal Health Research Institute
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 0C7
- River Valley Health c/o Stan Cassidy Centre for Rehabilitation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
- QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital General Campus
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
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California
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Los Angeles, California, United States, 90033
- USC, Keck School of Medicine Health Care Consultation Center
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Sacramento, California, United States, 95817
- UC Davis
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Georgia
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Atlanta, Georgia, United States, 30309
- Shepherd Center
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University MS Center
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Maryland
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Baltimore, Maryland, United States, 21201
- Maryland Center for MS
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University, Department of Neurology
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Minnesota
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Golden Valley, Minnesota, United States, 55422
- The Schapiro Center for MS
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine, Div. of Rehab/Neurology
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Montana
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Great Falls, Montana, United States, 59405
- Advanced Neurology Specialists
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New Jersey
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Teaneck, New Jersey, United States, 07666
- Gimbel MS Center at Holy Name Hospital
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New York
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Brooklyn, New York, United States, 11219
- Maimonides MS Care Center
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New York, New York, United States, 10029
- Corinne Goldsmith Dickinson Center for MS
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Rochester, New York, United States, 14642
- University of Rochester
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Stony Brook, New York, United States, 11794
- SUNY Stony Brook
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North Carolina
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Charlotte, North Carolina, United States, 28207
- CMC - Neuroscience & Spine Institute, Division of Neurology
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Raleigh, North Carolina, United States, 27607
- Raleigh Neurology Associates
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43221
- Ohio State University MS Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University, MS Center of Oregon, UHS-42
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Physicians
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital, Allegheny Neurological Associates
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Texas
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Houston, Texas, United States, 77030
- University of Texas-Houston
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Vermont
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Bennington, Vermont, United States, 05201
- Neurological Research Center, Inc.
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care
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Washington
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Kirkland, Washington, United States, 98034
- MS Center at Evergreen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Summary of Treatment Emergent Adverse Events (TEAE).
Time Frame: up to 5 years
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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.
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up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Timed 25 Foot Walk (T25FW)
Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit
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Week 2, 14, 26, continuing every 26 weeks until the Final Visit
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Subject Global Impression (SGI)
Time Frame: visit 1 and every clinic visit
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Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS). 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
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Clinician Global Impression of Change (CGIC)
Time Frame: visit 1 and every clinic visit
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Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS. 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
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Expanded Disability Status Scale (EDSS)
Time Frame: Screening visit, visit 6 and every 24 months thereafter
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Each patient, based on their baseline neurological exam, are scored according to the EDSS The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable. |
Screening visit, visit 6 and every 24 months thereafter
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bonnie Faust, Acorda Therapeutics
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Potassium Channel Blockers
- 4-Aminopyridine
Other Study ID Numbers
- MS-F203EXT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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