Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine
Intervention description: Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Quality of Life; Multiple Sclerosis

Summary:

      The primary objective of the study is to assess the effect of long-term treatment with
      prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale
      (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment
      responders. The secondary objectives of this study are to compare the change in the PCS of
      the SF-36 between treatment responders and non-responders, to evaluate change from baseline
      in additional quality of life measures among treatment responders as well as changes from
      baseline in treatment responders versus non-responders and to assess the safety and
      tolerability of prolonged-release fampridine 10 mg twice daily.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and authorization to use protected health information in accordance
             with national and local subject privacy regulations.

          -  Must have a diagnosis of primary-progressive, secondary-progressive,
             progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised
             McDonald Committee criteria ([Polman et al, 2011]) as defined by Lublin and Reingold
             [Lublin and Reingold 1996] of at least 3 months duration.

          -  Have a walking impairment as determined by the Investigator.

          -  Able to perform the Timed 25-foot Walk Test with or without a walking aid.

          -  Female subjects of childbearing potential must practice effective contraception during
             the study and be willing and able to continue contraception for 30 days after their
             last dose of study treatment.

          -  Able to understand and comply with the requirements of the protocol.

        Key Exclusion Criteria:

          -  Known allergy to pyridine-containing substances or to any of the inactive ingredients
             in the prolonged-release fampridine tablet.

          -  Any history of seizure, epilepsy, or other convulsive disorder, with the exception of
             febrile seizures in childhood.

          -  An estimated creatinine clearance of <80 mL/minute.

          -  Subject needs to take medicinal products that are inhibitors of organic cation
             transporter 2 (OCT2 [e.g., cimetidine]).

          -  Female subjects who are currently pregnant or who are considering becoming pregnant
             while participating in the study.

          -  Female subjects who are currently breastfeeding.

          -  Previous exposure to fampridine.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.