LIBERATE: An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT01480063
Collaborator
(none)
4,734
168
81.8
28.2
0.3
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
4734 participants
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)
Actual Study Start Date
:
Apr 16, 2012
Actual Primary Completion Date
:
Feb 8, 2019
Actual Study Completion Date
:
Feb 8, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fampyra Fampyra administered as prescribed in routine clinical practice. |
Drug: Fampridine
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Adverse Events [Day 1 up to one year]
Secondary Outcome Measures
- Utilization patterns of Fampyra in Routine Clinical Practice [Day 1 up to one year]
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.
- Effectiveness of risk minimization measures [Day 1 up to one year]
Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.
- 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]
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.
- 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]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Ciudad Autonoma de Buanos Aires | Buenos Aires | Argentina | |
| 2 | Research Site | Rosario | Santa Fe | Argentina | |
| 3 | Research Site | Buenos Aires | Argentina | C10161ABD | |
| 4 | Research Site | Cordoba | Argentina | ||
| 5 | Research Site | Salta | Argentina | ||
| 6 | Research Site | Burnaby | British Colombia | Canada | V5H 4K7 |
| 7 | Research Site | Fredericton | New Brunswick | Canada | E3B 0C7 |
| 8 | Research Site | Brampton | Ontario | Canada | L6W 2Z8 |
| 9 | Reasearch Center | London | Ontario | Canada | N6A 5A5 |
| 10 | Research Site | London | Ontario | Canada | N6A 5A5 |
| 11 | Research Site | Ottawa | Ontario | Canada | K1H 8L6 |
| 12 | Research Site | Brno | Czechia | ||
| 13 | Research Site | Olomouc | Czechia | ||
| 14 | Research Site | Pardubice | Czechia | ||
| 15 | Research Site | Praha 10 | Czechia | ||
| 16 | Research Site | Praha 2 | Czechia | ||
| 17 | Research Site | Agen cedex 09 | Lot Et Garonne | France | 47923 |
| 18 | Research Site | Rouen | Sein Maritime | France | 76031 |
| 19 | Research Site | Bois-Guillaume | Seine-Maritime | France | 76230 |
| 20 | Research Site | Angers | France | ||
| 21 | Research Site | Bayonne | France | ||
| 22 | Research Site | Bordeaux Cedex | France | ||
| 23 | Research Site | Bron Cedex | France | ||
| 24 | Research Site | Caen | France | ||
| 25 | Research Site | Cahors cedex 6 | France | ||
| 26 | Research Site | Cergy | France | ||
| 27 | Research Site | Colmar | France | ||
| 28 | Research Site | Dax cedex | France | ||
| 29 | Research Site | Dijon Cedex | France | ||
| 30 | Research Site | Dijon | France | ||
| 31 | Research Site | Gonesse | France | ||
| 32 | Research Site | La Seyne sur Mer | France | ||
| 33 | Research Site | Le Mans cedex 09 | France | ||
| 34 | Research Site | Lille cedex | France | ||
| 35 | Research Site | Limoges | France | ||
| 36 | Research Site | Lisieux | France | ||
| 37 | Research Site | Lyon | France | ||
| 38 | Research Site | Mantes La Jolie cedex | France | ||
| 39 | Research Site | Marseille | France | ||
| 40 | Research Site | Montauban | France | ||
| 41 | Research Site | Montbéliard cedex | France | ||
| 42 | Research Site | Montluçon | France | ||
| 43 | Research Site | Montpellier cedex 5 | France | ||
| 44 | Research Site | Montpellier | France | ||
| 45 | Research Site | Nancy | France | ||
| 46 | Research Site | Nimes | France | ||
| 47 | Research Site | Niort Cedex | France | ||
| 48 | Research Site | Orléans | France | ||
| 49 | Research Site | Paris cedex 19 | France | ||
| 50 | Research Site | Paris | France | ||
| 51 | Research Site | Poitiers cedex | France | ||
| 52 | Research Site | Pringy cedex | France | ||
| 53 | Research Site | Quimper cedex | France | ||
| 54 | Research Site | Rambouillet | France | ||
| 55 | Research Site | Roanne cedex | France | ||
| 56 | Research Site | Rouen | France | ||
| 57 | Research Site | Rueil Malmaison | France | ||
| 58 | Research Site | Saint Malo cedex | France | ||
| 59 | Research Site | Toulouse | France | ||
| 60 | Research Site | Tourcoing cedex | France | ||
| 61 | Research Site | Vichy Cedex | France | ||
| 62 | Research Site | Sindelfingen | Baden Wuerttemberg | Germany | 71034 |
| 63 | Research Site | Karlstadt | Bayern | Germany | 97753 |
| 64 | Research Site | Lohr Am Main | Bayern | Germany | 97816 |
| 65 | Research Site | Muenchen | Bayern | Germany | 81825 |
| 66 | Research Site | Neusass | Bayern | Germany | 86356 |
| 67 | Research Site | Gottingen | Niedersachsen | Germany | 37073 |
| 68 | Research Site | Wermsdorf | Nordsachsen | Germany | 04779 |
| 69 | Research Site | Homburg | Saarland | Germany | 66421 |
| 70 | Research Site | Stadtroda | Thuringia | Germany | 07646 |
| 71 | Research Site | Abensberg | Germany | ||
| 72 | Research Site | Altenholz | Germany | ||
| 73 | Research Site | Aschaffenburg | Germany | ||
| 74 | Research Site | Bad Krozingen | Germany | ||
| 75 | Research Site | Bamberg | Germany | ||
| 76 | Research Site | Bayreuth | Germany | ||
| 77 | Research Site | Berlin | Germany | ||
| 78 | Research Site | Bochum | Germany | ||
| 79 | Research Site | Bogen | Germany | ||
| 80 | Research Site | Bonn | Germany | ||
| 81 | Research Site | Butzbach | Germany | ||
| 82 | Research Site | Eisenach | Germany | ||
| 83 | Research Site | Erbach | Germany | ||
| 84 | Research Site | Essen | Germany | ||
| 85 | Research Site | Frankfurt | Germany | ||
| 86 | Research Site | Freiburg | Germany | ||
| 87 | Research Site | Grevenbroich | Germany | ||
| 88 | Research Site | Hagen | Germany | ||
| 89 | Research Site | Hamburg | Germany | ||
| 90 | Research Site | Herford | Germany | ||
| 91 | Research Site | Itzehoe | Germany | ||
| 92 | Research Site | Kastellaun | Germany | ||
| 93 | Research Site | Landshut | Germany | ||
| 94 | Research Site | Lappersdorf | Germany | ||
| 95 | Research Site | Leipzig | Germany | ||
| 96 | Research Site | Mannheim | Germany | ||
| 97 | Research Site | Muenchen | Germany | ||
| 98 | Research Site | Neu-Ulm | Germany | ||
| 99 | Research Site | Neuburg | Germany | ||
| 100 | Research Site | Oldenburg | Germany | ||
| 101 | Research Site | Ostfildern | Germany | ||
| 102 | Research Site | Ravensburg | Germany | ||
| 103 | Research Site | Singen | Germany | ||
| 104 | Research Site | Sinsheim | Germany | ||
| 105 | Research Site | Stade | Germany | ||
| 106 | Research Site | Stuttgart | Germany | ||
| 107 | Research Site | Trier | Germany | ||
| 108 | Research Site | Ulm | Germany | ||
| 109 | Research Site | Unterhaching | Germany | ||
| 110 | Research Site | Dublin | Ireland | ||
| 111 | Research Site | Haifa | Israel | ||
| 112 | Research Site | Jerusalem | Israel | ||
| 113 | Research Site | Tel Aviv | Israel | ||
| 114 | Research Site | Beirut | Lebanon | ||
| 115 | Research Site | Almelo | Netherlands | ||
| 116 | Research Site | Amsterdam | Netherlands | ||
| 117 | Research Site | Arnhem | Netherlands | 6800 TA | |
| 118 | Research Site | Blaricum | Netherlands | ||
| 119 | Research Site | Breda | Netherlands | ||
| 120 | Research Site | Dordrecht | Netherlands | ||
| 121 | Research Site | Eindhoven | Netherlands | ||
| 122 | Research Site | Emmen | Netherlands | ||
| 123 | Research Site | Enschede | Netherlands | ||
| 124 | Research Site | Gouda | Netherlands | ||
| 125 | Research Site | Groningen | Netherlands | ||
| 126 | Research Site | Heerenveen | Netherlands | 8441 PW | |
| 127 | Research Site | Hoorn | Netherlands | ||
| 128 | Research Site | Leeuwarden | Netherlands | ||
| 129 | Research Site | Leiden | Netherlands | ||
| 130 | Research Site | Meppel | Netherlands | ||
| 131 | Research Site | Nieuwegein | Netherlands | ||
| 132 | Research Site | Nijmegen | Netherlands | 6500 GS | |
| 133 | Research Site | Rotterdam | Netherlands | ||
| 134 | Research Site | Sittard Geleen | Netherlands | 6162 BG | |
| 135 | Research Site | Sneek | Netherlands | ||
| 136 | Research Site | Tilburg | Netherlands | ||
| 137 | Research Site | Venlo | Netherlands | ||
| 138 | Research Site | Vlissingen | Netherlands | ||
| 139 | Rsearch Site | Zutphen | Netherlands | ||
| 140 | Research Site | Bergen | Norway | ||
| 141 | Research Site | Molde | Norway | ||
| 142 | Research Site | Stavanger | Norway | ||
| 143 | Research Site | Amadora | Portugal | ||
| 144 | Research Site | Braga | Portugal | ||
| 145 | Research Site | Faro | Portugal | ||
| 146 | Research Site | Guimaraes | Portugal | ||
| 147 | Research Site | Lisboa | Portugal | ||
| 148 | Research Site | Loures | Portugal | ||
| 149 | Research Site | Matosinhos | Portugal | ||
| 150 | Research Site | Porto | Portugal | ||
| 151 | Research Site | Viana do Castelo | Portugal | ||
| 152 | Research Site | Palma de Mallorca | Baleares | Spain | 07010 |
| 153 | Research Site | Getafe | Madrid | Spain | |
| 154 | Research Site | Pamplona | Navarra | Spain | |
| 155 | Research site | San Cristobal de La laguna | Tenerife | Spain | |
| 156 | Site Research | Bilbao | Vizcaya | Spain | |
| 157 | Research Site | Alicante | Spain | ||
| 158 | Research Site | Avila | Spain | ||
| 159 | Research Site | Caceres | Spain | ||
| 160 | Research Site | Cordoba | Spain | ||
| 161 | Research Site | La Coruña | Spain | ||
| 162 | Research Site | Madrid | Spain | ||
| 163 | Research Site | Málaga | Spain | ||
| 164 | Research Site | Segovia | Spain | ||
| 165 | Research Site | Valladolid | Spain | ||
| 166 | Research Site | Zaragoza | Spain | ||
| 167 | Research Site | Abu Dhabi | United Arab Emirates | ||
| 168 | Research Site | Dubai | United Arab Emirates |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT01480063
Other Study ID Numbers:
- 218MS401
First Posted:
Nov 28, 2011
Last Update Posted:
Jun 5, 2019
Last Verified:
Jun 1, 2019