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. (see Contacts and Locations)
Verified April 2015 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01480063
First received: November 23, 2011
Last updated: April 9, 2015
Last verified: April 2015

November 23, 2011
April 9, 2015
April 2012
December 2020   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Day 1 up to one year ] [ Designated as safety issue: Yes ]
Collection of safety data in MS patients taking Famprya in routine clinical practice [ Time Frame: Over a period of one year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Characterize utilisation patterns of Fampryra in routine clinical practice [ Time Frame: Over a period of one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

This post marketing study will be carried out by neurologists in routine clinical settings.

Multiple Sclerosis
Drug: Fampridine
Fampyra administered as prescribed in routine clinical practice. Biogen Idec is not supplying drug for this study.
Other Names:
  • BIIB041
  • fampridine prolonged-release tablets
  • Ampyra
  • Fampyra
Fampyra
Fampyra administered as prescribed in routine clinical practice.
Intervention: Drug: Fampridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 2020
December 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:

  • None

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

Both
Not Provided
No
Contact: Biogen clinicaltrials@biogen.com
Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Ireland,   Israel,   Norway,   Portugal,   Spain
 
NCT01480063
218MS401
Not Provided
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP