Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
NCT ID: NCT06916507
Last Updated: 2025-09-08
Study Results
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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RECRUITING
125 participants
OBSERVATIONAL
2025-05-06
2027-09-30
Brief Summary
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Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.
Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
* Participant must be an adult male or female, 18-64 years of age
* Time since beginning of motor fluctuations ≤ 3 years
* The Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition
* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study
Exclusion Criteria
* Any condition included in the contraindications section of the approved local LDp/CDp label.
* Participants with Mini mental state examination (MMSE) score \< 24
18 Years
64 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Universitaetsklinikum Heidelberg /ID# 274164
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 275828
Tübingen, Baden-Wurttemberg, Germany
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
Ulm, Baden-Wurttemberg, Germany
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
Wolfach, Baden-Wurttemberg, Germany
Klinikum der Universitaet Muenchen Grosshadern /ID# 274168
Munich, Bavaria, Germany
Klinikum Ernst von Bergmann /ID# 274176
Potsdam, Brandenburg, Germany
Universitaetskliniken Giessen und Marburg /ID# 274224
Marburg, Hesse, Germany
Knappschaftskrankenhaus Bottrop /ID# 274284
Bottrop, North Rhine-Westphalia, Germany
Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167
Dresden, Saxony, Germany
Krankenhaus Martha-Maria Halle-Dölau /ID# 274174
Halle, Saxony-Anhalt, Germany
Praxis MD Oehlwein /ID# 274222
Gera, Thuringia, Germany
Asklepios Fachklinikum Stadtroda /ID# 274162
Stadtroda, Thuringia, Germany
Countries
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Central Contacts
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Related Links
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Other Identifiers
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P25-278
Identifier Type: -
Identifier Source: org_study_id
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