Clinical trial NCT01480063: An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-11-28
Enrollment: 4734
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This post marketing study will be carried out by neurologists in routine clinical settings.

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).


Eligibility criteria: Key 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.

Key Exclusion Criteria:

* None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Day 1 up to one year
Secondary outcomes:
measure: Utilization patterns of Fampyra in Routine Clinical Practice
timeFrame: Day 1 up to one year
measure: Effectiveness of risk minimization measures
timeFrame: Day 1 up to one year
measure: 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
timeFrame: Baseline, Day 1 up to one year
measure: Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)
timeFrame: Baseline, Months 3, 6, 9, 12
Other outcomes:
Locations:
city: Ciudad Autonoma de Buanos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Salta
country: Argentina
facility: Research Site
city: Burnaby
country: Canada
facility: Research Site
state: British Colombia
city: Fredericton
country: Canada
facility: Research Site
state: New Brunswick
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Reasearch Center
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Brno
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Agen cedex 09
country: France
facility: Research Site
state: Lot Et Garonne
city: Rouen
country: France
facility: Research Site
state: Sein Maritime
city: Bois-Guillaume
country: France
facility: Research Site
state: Seine-Maritime
city: Angers
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Bron Cedex
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Cahors cedex 6
country: France
facility: Research Site
city: Cergy
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Dax cedex
country: France
facility: Research Site
city: Dijon Cedex
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Gonesse
country: France
facility: Research Site
city: La Seyne sur Mer
country: France
facility: Research Site
city: Le Mans cedex 09
country: France
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city: Lille cedex
country: France
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city: Limoges
country: France
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city: Lisieux
country: France
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city: Lyon
country: France
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city: Mantes La Jolie cedex
country: France
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city: Marseille
country: France
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city: Montauban
country: France
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city: Montbéliard cedex
country: France
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city: Montluçon
country: France
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city: Montpellier cedex 5
country: France
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city: Montpellier
country: France
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city: Nancy
country: France
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city: Nimes
country: France
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city: Niort Cedex
country: France
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city: Orléans
country: France
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city: Paris cedex 19
country: France
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city: Paris
country: France
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city: Poitiers cedex
country: France
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city: Pringy cedex
country: France
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city: Quimper cedex
country: France
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city: Rambouillet
country: France
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city: Roanne cedex
country: France
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city: Rouen
country: France
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city: Rueil Malmaison
country: France
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city: Saint Malo cedex
country: France
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city: Toulouse
country: France
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city: Tourcoing cedex
country: France
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city: Vichy Cedex
country: France
facility: Research Site
city: Sindelfingen
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Karlstadt
country: Germany
facility: Research Site
state: Bayern
city: Lohr Am Main
country: Germany
facility: Research Site
state: Bayern
city: Muenchen
country: Germany
facility: Research Site
state: Bayern
city: Neusass
country: Germany
facility: Research Site
state: Bayern
city: Gottingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Wermsdorf
country: Germany
facility: Research Site
state: Nordsachsen
city: Homburg
country: Germany
facility: Research Site
state: Saarland
city: Stadtroda
country: Germany
facility: Research Site
state: Thuringia
city: Abensberg
country: Germany
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city: Altenholz
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city: Aschaffenburg
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city: Bad Krozingen
country: Germany
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city: Bamberg
country: Germany
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country: Germany
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city: Berlin
country: Germany
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city: Bochum
country: Germany
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city: Bogen
country: Germany
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city: Bonn
country: Germany
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city: Butzbach
country: Germany
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city: Eisenach
country: Germany
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city: Erbach
country: Germany
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city: Essen
country: Germany
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city: Frankfurt
country: Germany
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city: Freiburg
country: Germany
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city: Grevenbroich
country: Germany
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city: Hagen
country: Germany
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city: Hamburg
country: Germany
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country: Germany
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city: Itzehoe
country: Germany
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city: Kastellaun
country: Germany
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city: Landshut
country: Germany
facility: Research Site
city: Lappersdorf
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Neu-Ulm
country: Germany
facility: Research Site
city: Neuburg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
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city: Ostfildern
country: Germany
facility: Research Site
city: Ravensburg
country: Germany
facility: Research Site
city: Singen
country: Germany
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city: Sinsheim
country: Germany
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city: Stade
country: Germany
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city: Stuttgart
country: Germany
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city: Trier
country: Germany
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city: Ulm
country: Germany
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city: Unterhaching
country: Germany
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city: Dublin
country: Ireland
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city: Haifa
country: Israel
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city: Jerusalem
country: Israel
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city: Tel Aviv
country: Israel
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city: Beirut
country: Lebanon
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city: Almelo
country: Netherlands
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city: Amsterdam
country: Netherlands
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city: Arnhem
country: Netherlands
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city: Blaricum
country: Netherlands
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city: Breda
country: Netherlands
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city: Dordrecht
country: Netherlands
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city: Eindhoven
country: Netherlands
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city: Emmen
country: Netherlands
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city: Enschede
country: Netherlands
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city: Gouda
country: Netherlands
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city: Groningen
country: Netherlands
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city: Heerenveen
country: Netherlands
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city: Hoorn
country: Netherlands
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city: Leeuwarden
country: Netherlands
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city: Leiden
country: Netherlands
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city: Meppel
country: Netherlands
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city: Nieuwegein
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Sittard Geleen
country: Netherlands
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city: Sneek
country: Netherlands
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city: Tilburg
country: Netherlands
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city: Venlo
country: Netherlands
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city: Vlissingen
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Rsearch Site
city: Bergen
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Guimaraes
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Loures
country: Portugal
facility: Research Site
city: Matosinhos
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Getafe
country: Spain
facility: Research Site
state: Madrid
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: San Cristobal de La laguna
country: Spain
facility: Research site
state: Tenerife
city: Bilbao
country: Spain
facility: Site Research
state: Vizcaya
city: Alicante
country: Spain
facility: Research Site
city: Avila
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: La Coruña
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Segovia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.