Trials / Completed
CompletedNCT01480063
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,734 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fampridine | Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study. |
Timeline
- Start date
- 2012-04-16
- Primary completion
- 2019-02-08
- Completion
- 2019-02-08
- First posted
- 2011-11-28
- Last updated
- 2019-06-05
Locations
164 sites across 13 countries: Argentina, Canada, Czechia, France, Germany, Ireland, Israel, Lebanon, Netherlands, Norway, Portugal, Spain, United Arab Emirates
Source: ClinicalTrials.gov record NCT01480063. Inclusion in this directory is not an endorsement.