Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease

NCT06965374 | Recruiting

• 1 other identifier: P25-246
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 19

Brief Summary

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 Foslevodopa/Foscarbidopa is in treating Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present). Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 270 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 19 sites in Italy. 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Foslevodopa/Foscarbidopa

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Quality of Life as Measured by PD Questionnaire-39 (PDQ-39) Summary Index

  The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.

  Up to approximately 6 months

Study Arms (1)

Foslevodopa/Foscarbidopa

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with advanced Parkinson disease treated with Foslevodopa/Foscarbidopa according to label in Italy

You may qualify if:

• 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
• h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

IRCCS Oasi SS. Troina /ID# 273507

Troina, Enna, 94018, Italy

RECRUITING

Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695

Pozzilli, Isernia, 86077, Italy

RECRUITING

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949

Milan, Milano, 20122, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225

Milan, Milano, 20133, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434

Naples, Napoli, 80138, Italy

RECRUITING

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276

Turin, Piedmont, 10126, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834

Rome, Roma, 00133, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562

Rome, Roma, 00161, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539

Rome, Roma, 00168, Italy

RECRUITING

Azienda Ulss 3 Serenissima /ID# 273027

Venice, Venezia, 30100, Italy

RECRUITING

Azienda Ospedaliero Universitaria delle Marche /ID# 272694

Ancona, 60020, Italy

RECRUITING

Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463

Bologna, 40139, Italy

RECRUITING

IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628

Messina, 98124, Italy

RECRUITING

Azienda Ospedale-Universita Padova /ID# 274317

Padova, 35128, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863

Palermo, 90127, Italy

RECRUITING

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana /ID# 273541

Pisa, 56126, Italy

RECRUITING

AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388

Reggio Emilia, 42122, Italy

RECRUITING

AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319

Salerno, 84131, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Caterina Golotta

CONTACT

+39 06 548891; caterina.golotta@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

IT (19)