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
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01480063
First received: November 23, 2011
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention
Multiple Sclerosis
Drug: Fampridine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Day 1 up to one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Study Start Date: April 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fampyra
Fampyra administered as prescribed in routine clinical practice.
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480063

Contacts
Contact: Biogen clinicaltrials@biogen.com

  Show 166 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01480063     History of Changes
Other Study ID Numbers: 218MS401
Study First Received: November 23, 2011
Last Updated: April 9, 2015
Health Authority: Canada: Ethics Review Committee
Norway: Ethics Committee
France: Conseil National de l'Ordre des Médecins (CNOM)
Argentina: Human Research Bioethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Israel: Ethics Commission

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015