Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine-SR b.i.d. (Twice Daily)
Intervention description: Dosage form - tablets.
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 177.0
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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.