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
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine-SR
Intervention description: Tablets, 10 mg, BID
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 269.0
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 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.
    

Eligibility criteria:

        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