Status:

RECRUITING

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

Lead Sponsor:

AbbVie

Conditions:

Parkinson Disease

Eligibility:

All Genders

18+ years

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 tremor...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 4 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT06965374

Start Date

June 4 2025

End Date

June 1 2027

Last Update

December 22 2025

Active Locations (17)

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Page 1 of 5 (17 locations)

1

IRCCS Oasi SS. Troina /ID# 273507

Troina, Enna, Italy, 94018

2

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

Pozzilli, Isernia, Italy, 86077

3

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

Milan, Milano, Italy, 20122

4

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225

Milan, Milano, Italy, 20133