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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fampyra | Fampyra administered as prescribed in routine clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine | Drug | Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Day 1 up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effectiveness of risk minimization measures |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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This post marketing study will be carried out by neurologists in routine clinical settings.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ciudad Autonoma de Buanos Aires | Buenos Aires | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34322853 | Derived | 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. |
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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 |
| 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 |
| 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 |
| 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 |
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| Research Site | Dijon | France |
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| Research Site | La Seyne-sur-Mer | France |
| Research Site | Le Mans | France |
| Research Site | Lille | France |
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| Research Site | Sindelfingen | Baden-Wurttemberg | 71034 | Germany |
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| 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 |
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| Research Site | Homburg | Saarland | 66421 | Germany |
| Research Site | Stadtroda | Thuringia | 07646 | Germany |
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| Research Site | Haifa | Israel |
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| Research Site | Arnhem | 6800 TA | Netherlands |
| Research Site | Blaricum | Netherlands |
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| Research Site | Flushing | Netherlands |
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| 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 |
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| Rsearch Site | Zutphen | Netherlands |
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| Research Site | Molde | Norway |
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| Research Site | Braga | Portugal |
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| Research Site | Guimarães | Portugal |
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| Research Site | Matosinhos Municipality | Portugal |
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| 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 |
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| Research Site | Alicante | Spain |
| Research Site | Ávila | Spain |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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