Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)

NCT06916507 | Recruiting

• 1 other identifier: P25-278
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 13

Brief Summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice. 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Foscarbidopa/Foslevodopa

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in OFF Time (hours)

  The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).

  Up To 12 months

Study Arms (1)

Foslevodopa/Foscarbidopa

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with advanced Parkinson's disease with time since the beginning of motor fluctuations ≤3 years and the Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany

You may qualify if:

• Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
• 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

You may not qualify if:

• Previous Exposure to any device-aided therapy (DAT).
• Any condition included in the contraindications section of the approved local LDp/CDp label.
• Participants with Mini mental state examination (MMSE) score \< 24

Sponsors & Collaborators

• AbbVie: lead

Study Sites (13)

Universitaetsklinikum Heidelberg /ID# 274164

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Universitaetsklinikum Tuebingen /ID# 275828

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Praxis Prof. Kassubek/Prof. Riecker /ID# 274165

Ulm, Baden-Wurttemberg, 89073, Germany

RECRUITING

Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161

Wolfach, Baden-Wurttemberg, 77709, Germany

RECRUITING

Klinikum der Universitaet Muenchen Grosshadern /ID# 274168

Munich, Bavaria, 81337, Germany

NOT YET RECRUITING

Klinikum Ernst von Bergmann /ID# 274176

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Universitaetskliniken Giessen und Marburg /ID# 274224

Marburg, Hesse, 35043, Germany

RECRUITING

Knappschaftskrankenhaus Bottrop /ID# 274284

Bottrop, North Rhine-Westphalia, 46242, Germany

RECRUITING

Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865

Cologne, North Rhine-Westphalia, 50668, Germany

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167

Dresden, Saxony, 01307, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau /ID# 274174

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Praxis MD Oehlwein /ID# 274222

Gera, Thuringia, 07551, Germany

RECRUITING

Asklepios Fachklinikum Stadtroda /ID# 274162

Stadtroda, Thuringia, 07646, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Medical Information Germany

CONTACT

49 611 1720 1520; medinfo.germany@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

DE (13)