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
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine-SR
Intervention description: Tablets, 10 mg, BID (twice daily)
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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