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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 (LIBERATE)

This study is currently recruiting participants.
Verified December 2017 by Biogen
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480063
First Posted: November 28, 2011
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
November 23, 2011
November 28, 2011
December 4, 2017
April 16, 2012
December 31, 2020   (Final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Day 1 up to one year ]
Collection of safety data in MS patients taking Famprya in routine clinical practice [ Time Frame: Over a period of one year ]
Complete list of historical versions of study NCT01480063 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
Characterize utilisation patterns of Fampryra in routine clinical practice [ Time Frame: Over a period of one year ]
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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
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)
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
This post marketing study will be carried out by neurologists in routine clinical settings.
Multiple Sclerosis
Drug: Fampridine
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
Fampyra
Fampyra administered as prescribed in routine clinical practice.
Intervention: Drug: Fampridine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 31, 2020
December 31, 2020   (Final data collection date for primary outcome measure)

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:

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

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Biogen clinicaltrials@biogen.com
Argentina,   Canada,   Czechia,   France,   Germany,   Ireland,   Israel,   Lebanon,   Netherlands,   Norway,   Portugal,   Spain,   United Arab Emirates
Australia,   Belgium,   Czech Republic,   Denmark
 
NCT01480063
218MS401
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Biogen
Biogen
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Study Director: Medical Director Biogen
Biogen
December 2017