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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Biogen Idec
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01480063
First received: November 23, 2011
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

This is an observational study in MS patients that will take place in postmarketing routine clinical setting. The decision to enroll into study will not be made until the patient decides to begin treatment with Famprya (Dalfampridine). The investigators will be neurologists who will not perform any medical procedures outside the routine clinical practice. The data will be collected over a period of 12 months.


Condition
Multiple Sclerosis

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 Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Characterize utilisation patterns of Fampryra in routine clinical practice [ Time Frame: Over a period of one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, noninterventional, multicenter, observational study in MS patients with any disease subtype who are beginning Fampyra (fampridine) treatment in the postmarketing setting. The decision to enroll a patient into this study will not be made until after the neurologist and patient decide to begin Fampyra treatment and Fampyra has been prescribed.

Prescribing neurologists will be invited to participate in the study as Investigators. During the study, the Investigators should treat patients according to local clinical practice. Under the protocol, the Investigators are not required to perform any medical procedures that are outside of their normal clinical practice. Any cases of lack of efficacy or deterioration of a patient's health should be diagnosed and managed as per local guidelines. Data will be collected at Enrollment (Baseline) and Follow-Up. Follow-Up visits should occur according to clinical practice.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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.

Exclusion Criteria:

  • None
  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: Medical Director neurologyclinicaltrials@biogenidec.com

Locations
Germany
Research Site Recruiting
Neuberg, Germany
Norway
Molde Hospital Recruiting
Molde, Norway
Stavanger University Hospital Recruiting
Stavanger, Norway
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Ltd, Medical Director
ClinicalTrials.gov Identifier: NCT01480063     History of Changes
Other Study ID Numbers: 218MS401
Study First Received: November 23, 2011
Last Updated: July 5, 2012
Health Authority: Norway: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014