An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
LIBERATE
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)
1 other identifier
observational
4,734
13 countries
164
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedStudy Start
First participant enrolled
April 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2019
CompletedJune 5, 2019
June 1, 2019
6.8 years
November 23, 2011
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
Day 1 up to one year
Secondary Outcomes (4)
Utilization patterns of Fampyra in Routine Clinical Practice
Day 1 up to one year
Effectiveness of risk minimization measures
Day 1 up to one year
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
Baseline, Day 1 up to one year
Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)
Baseline, Months 3, 6, 9, 12
Study Arms (1)
Fampyra
Fampyra administered as prescribed in routine clinical practice.
Interventions
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Eligibility Criteria
This post marketing study will be carried out by neurologists in routine clinical settings.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (164)
Research Site
Ciudad Autonoma de Buanos Aires, Buenos Aires, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Buenos Aires, C10161ABD, Argentina
Research Site
Córdoba, Argentina
Research Site
Salta, Argentina
Research Site
Burnaby, British Colombia, V5H 4K7, Canada
Research Site
Fredericton, New Brunswick, E3B 0C7, Canada
Research Site
Brampton, Ontario, L6W 2Z8, Canada
Reasearch Center
London, Ontario, N6A 5A5, Canada
Research Site
London, Ontario, N6A 5A5, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Brno, Czechia
Research Site
Olomouc, Czechia
Research Site
Pardubice, Czechia
Research Site
Prague, Czechia
Research Site
Agen, Lot Et Garonne, 47923, France
Research Site
Rouen, Sein Maritime, 76031, France
Research Site
Bois-Guillaume, Seine-Maritime, 76230, France
Research Site
Angers, France
Research Site
Bayonne, France
Research Site
Bordeaux, France
Research Site
Bron, France
Research Site
Caen, France
Research Site
Cahors, France
Research Site
Cergy, France
Research Site
Colmar, France
Research Site
Dax, France
Research Site
Dijon, France
Research Site
Gonesse, France
Research Site
La Seyne-sur-Mer, France
Research Site
Le Mans, France
Research Site
Lille, France
Research Site
Limoges, France
Research Site
Lisieux, France
Research Site
Lyon, France
Research Site
Mantes-la-Jolie, France
Research Site
Marseille, France
Research Site
Montauban, France
Research Site
Montbéliard, France
Research Site
Montluçon, France
Research Site
Montpellier, France
Research Site
Nancy, France
Research Site
Niort, France
Research Site
Nîmes, France
Research Site
Orléans, France
Research Site
Paris, France
Research Site
Poitiers, France
Research Site
Pringy, France
Research Site
Quimper, France
Research Site
Rambouillet, France
Research Site
Roanne, France
Research Site
Rouen, France
Research Site
Rueil-Malmaison, France
Research Site
St-Malo, France
Research Site
Toulouse, France
Research Site
Tourcoing, France
Research Site
Vichy, France
Research Site
Sindelfingen, Baden-Wurttemberg, 71034, Germany
Research Site
Karlstadt am Main, Bavaria, 97753, Germany
Research Site
Lohr a. Main, Bavaria, 97816, Germany
Research Site
Munich, Bavaria, 81825, Germany
Research Site
Neusäß, Bavaria, 86356, Germany
Research Site
Göttingen, Lower Saxony, 37073, Germany
Research Site
Wermsdorf, Nordsachsen, 04779, Germany
Research Site
Homburg, Saarland, 66421, Germany
Research Site
Stadtroda, Thuringia, 07646, Germany
Research Site
Abensberg, Germany
Research Site
Altenholz, Germany
Research Site
Aschaffenburg, Germany
Research Site
Bad Krozingen, Germany
Research Site
Bamberg, Germany
Research Site
Bayreuth, Germany
Research Site
Berlin, Germany
Research Site
Bochum, Germany
Research Site
Bogen, Germany
Research Site
Bonn, Germany
Research Site
Butzbach, Germany
Research Site
Eisenach, Germany
Research Site
Erbach im Odenwald, Germany
Research Site
Essen, Germany
Research Site
Frankfurt, Germany
Research Site
Freiburg im Breisgau, Germany
Research Site
Grevenbroich, Germany
Research Site
Hagen, Germany
Research Site
Hamburg, Germany
Research Site
Herford, Germany
Research Site
Itzehoe, Germany
Research Site
Kastellaun, Germany
Research Site
Landshut, Germany
Research Site
Lappersdorf, Germany
Research Site
Leipzig, Germany
Research Site
Mannheim, Germany
Research Site
München, Germany
Research Site
Neu-Ulm, Germany
Research Site
Neuburg am Inn, Germany
Research Site
Oldenburg, Germany
Research Site
Ostfildern, Germany
Research Site
Ravensburg, Germany
Research Site
Singen, Germany
Research Site
Sinsheim, Germany
Research Site
Stade, Germany
Research Site
Stuttgart, Germany
Research Site
Trier, Germany
Research Site
Ulm, Germany
Research Site
Unterhaching, Germany
Research Site
Dublin, Ireland
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Tel Aviv, Israel
Research Site
Beirut, Lebanon
Research Site
Almelo, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Arnhem, 6800 TA, Netherlands
Research Site
Blaricum, Netherlands
Research Site
Breda, Netherlands
Research Site
Dordrecht, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Emmen, Netherlands
Research Site
Enschede, Netherlands
Research Site
Flushing, Netherlands
Research Site
Gouda, Netherlands
Research Site
Groningen, Netherlands
Research Site
Heerenveen, 8441 PW, Netherlands
Research Site
Hoorn, Netherlands
Research Site
Leeuwarden, Netherlands
Research Site
Leiden, Netherlands
Research Site
Meppel, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Nijmegen, 6500 GS, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Sittard Geleen, 6162 BG, Netherlands
Research Site
Sneek, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Venlo, Netherlands
Rsearch Site
Zutphen, Netherlands
Research Site
Bergen, Norway
Research Site
Molde, Norway
Research Site
Stavanger, Norway
Research Site
Amadora, Portugal
Research Site
Braga, Portugal
Research Site
Faro, Portugal
Research Site
Guimarães, Portugal
Research Site
Lisbon, Portugal
Research Site
Loures, Portugal
Research Site
Matosinhos Municipality, Portugal
Research Site
Porto, Portugal
Research Site
Viana do Castelo, Portugal
Research Site
Palma de Mallorca, Balearic Islands, 07010, Spain
Research Site
Getafe, Madrid, Spain
Research Site
Pamplona, Navarre, Spain
Research site
San Cristóbal de La Laguna, Tenerife, Spain
Site Research
Bilbao, Vizcaya, Spain
Research Site
A Coruña, Spain
Research Site
Alicante, Spain
Research Site
Ávila, Spain
Research Site
Cáceres, Spain
Research Site
Córdoba, Spain
Research Site
Madrid, Spain
Research Site
Málaga, Spain
Research Site
Segovia, Spain
Research Site
Valladolid, Spain
Research Site
Zaragoza, Spain
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Related Publications (1)
Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Trivino T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.
PMID: 34322853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
April 16, 2012
Primary Completion
February 8, 2019
Study Completion
February 8, 2019
Last Updated
June 5, 2019
Record last verified: 2019-06