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Recruiting NCT06937034

Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease

Observational Parkinson's Disease

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: from 18 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
Austria, Netherlands, Romania, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease

Overview

Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.

Primary outcome measures

  • Mean Base Infusion Rate [Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).]
  • Mean Low Infusion Rate [Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).]
  • Mean High Infusion Rate [Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).]

Eligibility criteria

Inclusion criteria

\- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.

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

Austria · 1 center
  • Medizinische Universitaet Graz /ID# 278569 — Graz
Netherlands · 1 center
  • Medisch Spectrum Twente /ID# 276695 — Enschede
Romania · 1 center
  • Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720 — Timișoara
Sweden · 1 center
  • Karolinska University Hospital Solna /ID# 277116 — Solna

Publications

  • Warnecke T, Van der Plas AA, Schwingenschuh P, Johansson A, Simu M, O'Meara M, Gupta R, Fritz B, Bergmann L, Parra JC, Sudmeyer M. Observational Retrospective Cohort of Patient Support Program Data on Practical Experiences of Treatment with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: The ORCHESTRA Study. Neurol Ther. 2026 Jun 20. doi: 10.1007/s40120-026-00978-0. Online ahead of print PMID 42322391

Identifiers

NCT: NCT06937034 · H25-878

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗