An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

Multiple Sclerosis Clinical Trial

— LIBERATE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480063
• Other study ID #: 218MS401
• Status: Completed
• Start date: April 16, 2012
• Est. completion date: February 8, 2019

Study information

• Verified date: June 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4734
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Fampridine
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buanos Aires	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Burnaby	British Colombia
Canada	Research Site	Fredericton	New Brunswick
Canada	Reasearch Center	London	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Ottawa	Ontario
Czechia	Research Site	Brno
Czechia	Research Site	Olomouc
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
France	Research Site	Agen cedex 09	Lot Et Garonne
France	Research Site	Angers
France	Research Site	Bayonne
France	Research Site	Bois-Guillaume	Seine-Maritime
France	Research Site	Bordeaux Cedex
France	Research Site	Bron Cedex
France	Research Site	Caen
France	Research Site	Cahors cedex 6
France	Research Site	Cergy
France	Research Site	Colmar
France	Research Site	Dax cedex
France	Research Site	Dijon
France	Research Site	Dijon Cedex
France	Research Site	Gonesse
France	Research Site	La Seyne sur Mer
France	Research Site	Le Mans cedex 09
France	Research Site	Lille cedex
France	Research Site	Limoges
France	Research Site	Lisieux
France	Research Site	Lyon
France	Research Site	Mantes La Jolie cedex
France	Research Site	Marseille
France	Research Site	Montauban
France	Research Site	Montbéliard cedex
France	Research Site	Montluçon
France	Research Site	Montpellier
France	Research Site	Montpellier cedex 5
France	Research Site	Nancy
France	Research Site	Nimes
France	Research Site	Niort Cedex
France	Research Site	Orléans
France	Research Site	Paris
France	Research Site	Paris cedex 19
France	Research Site	Poitiers cedex
France	Research Site	Pringy cedex
France	Research Site	Quimper cedex
France	Research Site	Rambouillet
France	Research Site	Roanne cedex
France	Research Site	Rouen
France	Research Site	Rouen	Sein Maritime
France	Research Site	Rueil Malmaison
France	Research Site	Saint Malo cedex
France	Research Site	Toulouse
France	Research Site	Tourcoing cedex
France	Research Site	Vichy Cedex
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
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Freiburg
Germany	Research Site	Gottingen	Niedersachsen
Germany	Research Site	Grevenbroich
Germany	Research Site	Hagen
Germany	Research Site	Hamburg
Germany	Research Site	Herford
Germany	Research Site	Homburg	Saarland
Germany	Research Site	Itzehoe
Germany	Research Site	Karlstadt	Bayern
Germany	Research Site	Kastellaun
Germany	Research Site	Landshut
Germany	Research Site	Lappersdorf
Germany	Research Site	Leipzig
Germany	Research Site	Lohr Am Main	Bayern
Germany	Research Site	Mannheim
Germany	Research Site	Muenchen
Germany	Research Site	Muenchen	Bayern
Germany	Research Site	Neu-Ulm
Germany	Research Site	Neuburg
Germany	Research Site	Neusass	Bayern
Germany	Research Site	Oldenburg
Germany	Research Site	Ostfildern
Germany	Research Site	Ravensburg
Germany	Research Site	Sindelfingen	Baden Wuerttemberg
Germany	Research Site	Singen
Germany	Research Site	Sinsheim
Germany	Research Site	Stade
Germany	Research Site	Stadtroda	Thuringia
Germany	Research Site	Stuttgart
Germany	Research Site	Trier
Germany	Research Site	Ulm
Germany	Research Site	Unterhaching
Germany	Research Site	Wermsdorf	Nordsachsen
Ireland	Research Site	Dublin
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Tel Aviv
Lebanon	Research Site	Beirut
Netherlands	Research Site	Almelo
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
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	Gouda
Netherlands	Research Site	Groningen
Netherlands	Research Site	Heerenveen
Netherlands	Research Site	Hoorn
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Leiden
Netherlands	Research Site	Meppel
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sittard Geleen
Netherlands	Research Site	Sneek
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Venlo
Netherlands	Research Site	Vlissingen
Netherlands	Rsearch Site	Zutphen
Norway	Research Site	Bergen
Norway	Research Site	Molde
Norway	Research Site	Stavanger
Portugal	Research Site	Amadora
Portugal	Research Site	Braga
Portugal	Research Site	Faro
Portugal	Research Site	Guimaraes
Portugal	Research Site	Lisboa
Portugal	Research Site	Loures
Portugal	Research Site	Matosinhos
Portugal	Research Site	Porto
Portugal	Research Site	Viana do Castelo
Spain	Research Site	Alicante
Spain	Research Site	Avila
Spain	Site Research	Bilbao	Vizcaya
Spain	Research Site	Caceres
Spain	Research Site	Cordoba
Spain	Research Site	Getafe	Madrid
Spain	Research Site	La Coruña
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Pamplona	Navarra
Spain	Research site	San Cristobal de La laguna	Tenerife
Spain	Research Site	Segovia
Spain	Research Site	Valladolid
Spain	Research Site	Zaragoza
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Argentina,  Canada,  Czechia,  France,  Germany,  Ireland,  Israel,  Lebanon,  Netherlands,  Norway,  Portugal,  Spain,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		Day 1 up to one year
Secondary	Utilization patterns of Fampyra in Routine Clinical Practice	Variables to be characterized include reason for Fampryra use, dose and duration of use, dosing deviations from local Fampyra label, and reasons for dosage changes.	Day 1 up to one year
Secondary	Effectiveness of risk minimization measures	Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.	Day 1 up to one year
Secondary	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	The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point scale that requires the clinician to rate the improvement or worsening of the overall walking ability of the patient.	Baseline, Day 1 up to one year
Secondary	Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)	The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.	Baseline, Months 3, 6, 9, 12