An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)
Recruitment status was Recruiting
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.
|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)|
- 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 ]
- Characterize utilisation patterns of Fampryra in routine clinical practice [ Time Frame: Over a period of one year ] [ Designated as safety issue: No ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480063
|Contact: Medical Directorfirstname.lastname@example.org|
|Stavanger University Hospital||Recruiting|