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

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT00648908
Run by: Acorda Therapeutics
People needed: 269
Starts: 2006-06-01
Expected to finish: 2011-04-01
Last updated by the study team: 2012-02-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
USC, Keck School of Medicine Health Care Consultation Center — Los Angeles, California, United States
UC Davis — Sacramento, California, United States
Shepherd Center — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
Indiana University MS Center — Indianapolis, Indiana, United States
Maryland Center for MS — Baltimore, Maryland, United States
Wayne State University, Department of Neurology — Detroit, Michigan, United States
The Schapiro Center for MS — Golden Valley, Minnesota, United States
Washington University School of Medicine, Div. of Rehab/Neurology — St Louis, Missouri, United States
Advanced Neurology Specialists — Great Falls, Montana, United States
Gimbel MS Center at Holy Name Hospital — Teaneck, New Jersey, United States
Maimonides MS Care Center — Brooklyn, New York, United States
Corinne Goldsmith Dickinson Center for MS — New York, New York, United States
University of Rochester — Rochester, New York, United States
SUNY Stony Brook — Stony Brook, New York, United States
CMC - Neuroscience & Spine Institute, Division of Neurology — Charlotte, North Carolina, United States
Raleigh Neurology Associates — Raleigh, North Carolina, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Ohio State University MS Center — Columbus, Ohio, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42 — Portland, Oregon, United States
Thomas Jefferson University Physicians — Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Allegheny Neurological Associates — Pittsburgh, Pennsylvania, United States
University of Texas-Houston — Houston, Texas, United States
Neurological Research Center, Inc. — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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