Foslevodopa/foscarbidopa infusion to improve quality of life for adults with advanced Parkinson disease
Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
This project will test whether subcutaneous foslevodopa/foscarbidopa helps quality of life for Italian adults with advanced, levodopa-responsive Parkinson disease and will also look at caregiver quality of life when a caregiver is present.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 19 sites (Troina, Enna and 18 other locations) |
| Trial ID | NCT06965374 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults in Italy with levodopa-responsive advanced Parkinson disease who have already been prescribed 24-hour subcutaneous foslevodopa/foscarbidopa according to local labeling and reimbursement rules are ideal candidates.
Not a fit: People with contraindications listed in the local foslevodopa/foscarbidopa label, those not responsive to levodopa, or those with relevant skin conditions may not receive benefit from this treatment or be eligible for participation.
Why it matters
Potential benefit: If successful, the findings could show that subcutaneous foslevodopa/foscarbidopa improves daily quality of life for people with advanced Parkinson disease and informs care decisions.
How similar studies have performed: Foslevodopa/foscarbidopa is an approved treatment and prior clinical trials have shown motor benefits, but there are limited real-world data specifically on long-term patient and caregiver quality of life.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Troina, Enna and 18 other locations
- 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)
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834 — Rome, Roma, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562 — Rome, Roma, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539 — Rome, Roma, Italy (Recruiting)
- Azienda Ulss 3 Serenissima /ID# 273027 — Venice, Venezia, Italy (Recruiting)
- Azienda Ospedaliero Universitaria delle Marche /ID# 272694 — Ancona, Italy (Recruiting)
- Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463 — Bologna, Italy (Recruiting)
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628 — Messina, Italy (Recruiting)
- Azienda Ospedale-Universita Padova /ID# 274317 — Padova, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863 — Palermo, Italy (Recruiting)
- Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226 — Pavia, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Pisana /ID# 273541 — Pisa, Italy (Recruiting)
- AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388 — Reggio Emilia, Italy (Recruiting)
- AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319 — Salerno, Italy (Recruiting)
Study contacts
- Study coordinator: Caterina Golotta
- Email: caterina.golotta@abbvie.com
- Phone: +39 06 548891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.