Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability
Overview
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.
Primary outcome measures
- Change From Baseline in OFF Time (hours) [Time frame: Up To 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 17 centers
- Universitaetsklinikum Heidelberg /ID# 274164 — Heidelberg
- Universitaetsklinikum Tuebingen /ID# 275828 — Tübingen
- Praxis Prof. Kassubek/Prof. Riecker /ID# 274165 — Ulm
- Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161 — Wolfach
- Universitaetsklinikum Erlangen /ID# 280831 — Erlangen
- Klinikum Ingolstadt /ID# 280573 — Ingolstadt
- Klinikum der Universitaet Muenchen Grosshadern /ID# 274168 — Munich
- Klinikum Ernst von Bergmann /ID# 274176 — Potsdam
- … and 9 more centers
Identifiers
NCT: NCT06916507 · P25-278