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An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

    • Biogen

    Project: Clinical Trial

    Project Details

    Description

    The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).
    AcronymLIBERATE
    StatusFinished
    Effective start/end date16/04/128/02/19

    Collaborative partners

    Keywords

    • Demyelinating Autoimmune Diseases, CNS
    • Autoimmune Diseases of the Nervous System
    • Nervous System Diseases
    • Demyelinating Diseases
    • Autoimmune Diseases
    • Immune System Diseases
    • Multiple Sclerosis
    • Potassium Channel Blockers
    • Membrane Transport Modulators
    • Molecular Mechanisms of Pharmacological Action
    • 4-Aminopyridine

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