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

November 23, 2011
July 5, 2012
April 2012
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01480063 on ClinicalTrials.gov Archive Site
Characterize utilisation patterns of Fampryra in routine clinical practice [ Time Frame: Over a period of one year ] [ Designated as safety issue: No ]
Same as current
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An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® 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)

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.

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.

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
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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 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Medical Director neurologyclinicaltrials@biogenidec.com
Germany,   Norway
 
NCT01480063
218MS401
Not Provided
Biogen Idec Ltd, Medical Director
Biogen Idec
Not Provided
Not Provided
Biogen Idec
July 2012

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