Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.

Key facts

Study ID

NCT00654927

Run by

Acorda Therapeutics

People needed

177

Starts

2003-11-01

Expected to finish

2011-04-01

Last updated by the study team

2012-03-02

Who can join

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

You may qualify if…

• The subject must have been previously enrolled in an Acorda Therapeutics or an Elan Corporation sponsored study for multiple sclerosis and received either Fampridine or placebo.
• The subject must have multiple sclerosis as determined by the Principal Investigator.
• The subject, male or female, 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.
• The subject must be of adequate cognitive function, as judged by the Investigator.
• Any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

You may not qualify if…

• The subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
• The subject withdrew from a previous Fampridine study because of a Serious Adverse Event that was possibly, probably or definitely related to Fampridine.
• The subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG.
• The subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening Visit, as judged by the Investigator
• The subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
• The subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine tablet
• The subject has received an investigational drug, except for Fampridine- SR (or matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit; or the subject is scheduled to enroll in an investigational drug trial at any time during this study.
• The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the Screening Visit.
• The subject has had an onset of an MS exacerbation within 30 days prior to the Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a prior exacerbation episode.
• The subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks.
• The 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
• Shepherd Center — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Maryland Center for MS — Baltimore, Maryland, 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
• Gimbel MS Center at Holy Name Hospital — Teaneck, New Jersey, United States
• University of Mexico, MIND Imaging Center — Albuquerque, New Mexico, 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
• 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
• University of Texas-Houston — Houston, Texas, United States
• MS Center at Evergreen — Kirkland, Washington, United States
• Foothills Medical Center — Calgary, Alberta, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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