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Completed

NCT Number: NCT01480063

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ciudad Autonoma de Buanos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.
  • Patients who are willing and able to provide written informed consent.

Key Exclusion Criteria:

  • None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Fampridine

Drug

Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.

Other names: Ampyra, dalfampridine, Fampyra, BIIB041, fampridine prolonged-release tablets

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Day 1 up to one year

Secondary outcomes

  1. Utilization patterns of Fampyra in Routine Clinical Practice

    Time frame: Day 1 up to one year

    Variables to be characterized include reason for Fampryra use, dose and duration of use, dosing deviations from local Fampyra label, and reasons for dosage changes.

  2. Effectiveness of risk minimization measures

    Time frame: Day 1 up to one year

    Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.

  3. Change from Baseline in Physician's Clinical Global Impression of Improvement (CGI-I) of Walking Ability Assessed Whenever the Multiple Sclerosis Participant is Seen by the Neurologist

    Time frame: Baseline, Day 1 up to one year

    The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point scale that requires the clinician to rate the improvement or worsening of the overall walking ability of the patient.

  4. Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)

    Time frame: Baseline, Months 3, 6, 9, 12

    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

Acronym: LIBERATE

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2011
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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