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

NCT ID: NCT01480063

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4734 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-16

Study Completion Date

2019-02-08

Brief Summary

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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).

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fampyra

Fampyra administered as prescribed in routine clinical practice.

Fampridine

Intervention Type DRUG

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

Interventions

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Fampridine

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

Intervention Type DRUG

Other Intervention Names

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Ampyra dalfampridine Fampyra BIIB041 fampridine prolonged-release tablets

Eligibility Criteria

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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.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Ciudad Autonoma de Buanos Aires, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Burnaby, British Colombia, Canada

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Fredericton, New Brunswick, Canada

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Brampton, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Brno, , Czechia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Agen, Lot Et Garonne, France

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Rouen, Sein Maritime, France

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Bois-Guillaume, Seine-Maritime, France

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Angers, , France

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Bayonne, , France

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Bordeaux, , France

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Bron, , France

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Caen, , France

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Cahors, , France

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Cergy, , France

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Colmar, , France

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Dax, , France

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Dijon, , France

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Gonesse, , France

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La Seyne-sur-Mer, , France

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Le Mans, , France

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Lille, , France

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Limoges, , France

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Lisieux, , France

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Lyon, , France

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Mantes-la-Jolie, , France

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Marseille, , France

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Montauban, , France

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Montbéliard, , France

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Montluçon, , France

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Montpellier, , France

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Nancy, , France

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Niort, , France

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Nîmes, , France

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Orléans, , France

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Paris, , France

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Poitiers, , France

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Pringy, , France

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Quimper, , France

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Rambouillet, , France

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Roanne, , France

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Rouen, , France

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Rueil-Malmaison, , France

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St-Malo, , France

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Toulouse, , France

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Tourcoing, , France

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Vichy, , France

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Sindelfingen, Baden-Wurttemberg, Germany

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Karlstadt am Main, Bavaria, Germany

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Lohr a. Main, Bavaria, Germany

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Munich, Bavaria, Germany

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Neusäß, Bavaria, Germany

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Göttingen, Lower Saxony, Germany

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Wermsdorf, Nordsachsen, Germany

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Homburg, Saarland, Germany

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Stadtroda, Thuringia, Germany

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Abensberg, , Germany

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Altenholz, , Germany

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Aschaffenburg, , Germany

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Bad Krozingen, , Germany

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Bamberg, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Bogen, , Germany

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Bonn, , Germany

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Butzbach, , Germany

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Eisenach, , Germany

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Erbach im Odenwald, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Grevenbroich, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Herford, , Germany

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Itzehoe, , Germany

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Kastellaun, , Germany

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Landshut, , Germany

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Lappersdorf, , Germany

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Leipzig, , Germany

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Mannheim, , Germany

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München, , Germany

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Neu-Ulm, , Germany

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Neuburg am Inn, , Germany

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Oldenburg, , Germany

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Ostfildern, , Germany

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Ravensburg, , Germany

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Singen, , Germany

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Sinsheim, , Germany

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Stade, , Germany

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Stuttgart, , Germany

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Trier, , Germany

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Ulm, , Germany

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Unterhaching, , Germany

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Dublin, , Ireland

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Haifa, , Israel

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Jerusalem, , Israel

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Tel Aviv, , Israel

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Beirut, , Lebanon

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Almelo, , Netherlands

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Blaricum, , Netherlands

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Breda, , Netherlands

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Dordrecht, , Netherlands

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Eindhoven, , Netherlands

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Emmen, , Netherlands

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Enschede, , Netherlands

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Flushing, , Netherlands

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Gouda, , Netherlands

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Groningen, , Netherlands

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Heerenveen, , Netherlands

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Hoorn, , Netherlands

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Leeuwarden, , Netherlands

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Leiden, , Netherlands

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Meppel, , Netherlands

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Nieuwegein, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Sittard Geleen, , Netherlands

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Sneek, , Netherlands

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Tilburg, , Netherlands

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Venlo, , Netherlands

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Zutphen, , Netherlands

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Bergen, , Norway

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Molde, , Norway

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Stavanger, , Norway

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Amadora, , Portugal

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Braga, , Portugal

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Faro, , Portugal

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Guimarães, , Portugal

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Lisbon, , Portugal

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Loures, , Portugal

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Matosinhos Municipality, , Portugal

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Porto, , Portugal

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Viana do Castelo, , Portugal

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Palma de Mallorca, Balearic Islands, Spain

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Getafe, Madrid, Spain

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Pamplona, Navarre, Spain

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San Cristóbal de La Laguna, Tenerife, Spain

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Bilbao, Vizcaya, Spain

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A Coruña, , Spain

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Alicante, , Spain

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Ávila, , Spain

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Cáceres, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Segovia, , Spain

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Valladolid, , Spain

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Zaragoza, , Spain

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Abu Dhabi, , United Arab Emirates

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Dubai, , United Arab Emirates

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Countries

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

References

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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.

Reference Type DERIVED
PMID: 34322853 (View on PubMed)

Other Identifiers

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218MS401

Identifier Type: -

Identifier Source: org_study_id

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