Real-world foslevodopa/foscarbidopa treatment for adults with early advanced Parkinson's in Germany

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational follow-up of about 125 adults who are prescribed subcutaneous foslevodopa/foscarbidopa during usual care across roughly 20 sites in Germany. Participants who meet criteria for early-stage advanced, levodopa-responsive Parkinson's disease will be followed for up to 12 months with regular clinic visits and data collection tied to routine care. Treatment is given as prescribed by the participant's clinician, with no experimental intervention or additional burden required beyond standard visits. The study aims to capture real-world effectiveness and tolerability in a defined early-advanced patient group rather than to test efficacy in a controlled trial.

Why it matters

Who can join: the full rules

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, 18-67 years of age
* Time since beginning of motor fluctuations \<= 5 years
* The Hoehn and Yahr (H\&Y) stage \<= 3
* 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

Where it's running

• Kliniken Schmieder - Allensbach /ID# 285402
  Allensbach, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Heidelberg /ID# 274164
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Tuebingen /ID# 275828
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
  Ulm, Baden-Wurttemberg, Germany Recruiting
• Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
  Wolfach, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Erlangen /ID# 280831
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Medical Information Germany
• Email: medinfo.germany@abbvie.com
• Phone: 49 611 1720 1520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.