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

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00649792

Run by

Acorda Therapeutics

People needed

214

Starts

2007-08-01

Expected to finish

2011-04-01

Last updated by the study team

2012-02-28

Who can join

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

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

Where it is running

• Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Neurological Associates — Fayetteville, Arkansas, United States
• Alta Bates Summit Medical Center - Research and Education Institute — Berkeley, California, United States
• USC, Keck School of Medicine Health Care Consultation Center — Los Angeles, California, United States
• UC Davis — Sacramento, California, United States
• Yale University MS Center — New Haven, Connecticut, United States
• Shepherd Center — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Consultants in Neurology, Ltd. — Northbrook, Illinois, United States
• Indiana University MS Center — Indianapolis, Indiana, United States
• Associates in Neurology, PSC — Lexington, Kentucky, United States
• Maryland Center for MS — Baltimore, Maryland, United States
• Lahey Clinic — Lexington, Massachusetts, 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 — St Louis, Missouri, United States
• Advanced Neurology Specialists — Great Falls, Montana, United States
• UMDNJ — Newark, New Jersey, United States
• Gimbel MS Center at Holy Name Hospital — Teaneck, New Jersey, United States
• Jacobs Neurological Institute Buffalo General Hospital — Buffalo, New York, United States
• Corinne Goldsmith Dickinson Center for MS — New York, New York, United States
• Columbia University Multiple Sclerosis Clinical Care Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.