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Real-World Study of Foslevodopa/Foscarbidopa for Advanced Parkinson's Disease

This study is looking at how well Foslevodopa/Foscarbidopa works for adults with advanced Parkinson's disease (PD) in real-world settings. Foslevodopa/Foscarbidopa is an approved medication for PD. The study will include about 100 participants, aged 18 to 80, who have been diagnosed with PD for less than 10 years and are already prescribed this medication by their doctor. We want to see if this treatment can reduce the amount of "OFF time" (when Parkinson's symptoms are not well controlled) over approximately 6 months. This will help us understand its effectiveness in routine care.

Study design
This is an observational study involving approximately 100 adult participants. It is designed to see how an approved medication works in a real-world setting.
What's involved
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician. The primary outcome will be measured up to approximately 6 months.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study will be measured up to approximately 6 months.

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NCT07227896

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

Recruiting
Not specifiedAges 18–80Observational
AbbVie
~100 participants
Updated 2026-09-01 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
Measured over Up to approximately 6 months

Conditions

Parkinson's Disease

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Parkinson Disease

NCT07227896

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arcadia Spitale Si Centre Medicale /Id# 277525

    Iași, Iaşi, Romaniano site contact published

    Recruiting

  • Fundeni Clinical Institute /ID# 277490

    Bucharest, Bucharest, Romaniano site contact published

    Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 276211

    Jerusalem, Israelno site contact published

    Recruiting

  • Neurotim Med /ID# 277500

    Timișoara, Timiș County, Romaniano site contact published

    Recruiting

  • Shaare Zedek Medical Center /ID# 276209

    Jerusalem, Jerusalem, Israelno site contact published

    Recruiting

  • Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499

    Brasov, Romaniano site contact published

    Not yet recruiting

  • Tel Aviv Sourasky Medical Center /ID# 276212

    Tel Aviv, Tel Aviv, Israelno site contact published

    Recruiting

  • Texas Movement Disorder Specialists /ID# 278565

    Georgetown, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

Lars Bergmann
[email protected]
+49(0)170 4538568
Email the study team

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Eligibility criteria

Inclusion

Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable
A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)
Adult male or female between 18 and 80 years of age
Disease duration (time since diagnosis) \<10 years
Time since motor fluctuations ≤3 years
H\&Y Stage \<3 in best "on"
"off" time of 2.5-6 hours per day
Naïve to LDp/CDp
Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator
Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study
Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).
Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered

Exclusion

History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country
History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa/Carbidopa Intestinal Gel (LCIG)/ Carbidopa/Levodopa Enteral Suspension (CLES), Levodopa/Entacapone/Carbidopa Intestinal Gel (LECIG)
Mini-Mental State Examination (MMSE) score \<24
Participation in a concurrent investigational or observational clinical trial
Lack of motivation/insufficient language skills to complete the study questionnaires
History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.

What this trial measures

  • Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IVUp to approximately 6 months

    The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD)