Foslevodopa/foscarbidopa infusion to improve quality of life for adults with advanced Parkinson disease

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 an observational, real-world study following about 270 adults with advanced, levodopa-responsive Parkinson disease who are prescribed 24-hour subcutaneous foslevodopa/foscarbidopa by their physicians. Participants receive the drug as part of routine care and are followed for up to 12 months with no additional study-mandated treatments. The study collects patient-reported quality of life measures and, when applicable, caregiver quality of life data to capture everyday outcomes outside a controlled trial setting. Data are being gathered across approximately 19 sites in Italy to characterize outcomes in routine clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD)
* Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study
* 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies

Exclusion Criteria:

* Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label
* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable
* History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments

Where it's running

• IRCCS Oasi SS. Troina /ID# 273507
  Troina, Enna, Italy Recruiting
• Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695
  Pozzilli, Isernia, Italy Recruiting
• ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949
  Milan, Milano, Italy Recruiting
• Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225
  Milan, Milano, Italy Recruiting
• Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434
  Naples, Napoli, Italy Recruiting
• A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276
  Turin, Piedmont, Italy Recruiting

Study contacts

• Study coordinator: Caterina Golotta
• Email: caterina.golotta@abbvie.com
• Phone: +39 06 548891

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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.