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NCT Number: NCT07227896

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

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 adult participants earlier within advanced Parkinson disease under routine clinical practice.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 40 sites across the world.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months.

There are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Medical Center Health System

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

    Time frame: Up 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)

Secondary outcomes

  1. Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

    Time frame: Up 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). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)

  2. Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

    Time frame: Up 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).

  3. Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

    Time frame: Up 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). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)

  4. Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index

    Time frame: Up to approximately 6 months

    The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable).

  5. Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)

    Time frame: Up to approximately 6 months

    The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each item is scored from 1 (best) to 5 (worst). An increase in the EQ-5D-5L score indicates a worsening.

  6. Change From Baseline in Motor experiences of daily living as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: Up 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). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.

  7. Change From Baseline in Disease-specific sleep disturbances as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score

    Time frame: Up to approximately 6 months

    The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]).

  8. Change From Baseline in Symptom severity measured by the Patient Global Impression of Severity (PGI-S)

    Time frame: Up to approximately 6 months

    The Patient Global Impression of Severity (PGI-S) is a single, patient-reported item that assesses the subject's perceived level of symptoms over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "no symptoms" (1) to "very severe" (5), with higher scores indicating greater severity.

  9. Change From Baseline in Symptom severity measured by the Patient Global Impression of Change (PGI-C)

    Time frame: Up to approximately 6 months

    The Patient Global Impression of Change (PGI-C)is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: Scores range from 1 = Very much improved; to 7 = Very much worse.

  10. Change From Baseline in Symptom severity measured by the Clinical Global Impression of Severity (CGI-S) scores

    Time frame: Up to approximately 6 months

    Clinical Global Impression of Severity (CGI-S) is a 7-point rating scale used to measure the that requires the clinician to assess how much the participant's illness has improved or worsened relative to the baseline state at the beginning of the intervention. Scores range from 1=normal; to 7=among the most extremely ill.

  11. Change From Baseline in Symptom severity measured by the Clinical Global Impression of Change (CGI-C) scores

    Time frame: Up to approximately 6 months

    The Clinical Global Impression of Change (CGI-C) is a clinician's impression of a subject's change in status on a 7-point scale. CGI-C scores range from 1 = very much improved to 7 = very much worse.

Other outcomes

  1. Change From Baseline in morning akinesia (early morning "off") as measured by by dedicated questionnaire.

    Time frame: Up to approximately 6 months

    Measured by dedicated questionnaire.

  2. Change From Baseline in Activities of daily living/independence as measured by the Schwab-England Activities of Daily Living Scale (SE-ADL)

    Time frame: Up to approximately 6 months

    Schwab-England Activities of Daily Living Scale (SE-ADL) onsists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.

  3. Change From Baseline in Self-efficacy as measured by the Self-efficacy for Managing Chronic Disease Scale (SEMCD)

    Time frame: Up to approximately 6 months

    Self-efficacy for Managing Chronic Disease Scale (SEMCD) Self-efficacy for chronic disease will be measured.

  4. Change From Baseline in Ability to reintegrate into normal social activity after illness as measured by the Reintegration to Normal Living Scale (RNLI) Scale

    Time frame: Up to approximately 6 months

    Reintegration to Normal Living Scale (RNLI) Scale the reintegrate into normal social activity after illness will be measured

  5. Change From Baseline in Treatment satisfaction, as measured by the Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score (TSQM-9)

    Time frame: Up to approximately 6 months

    Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score. an instrument to show that adherence is expected to be related with participants' satisfaction with therapy and that such satisfaction can be a function of not only the effect of the treatment, but also the services offered. Range of the domain scores range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).

  6. Change From Baseline in Stigma as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index

    Time frame: Up to approximately 6 months

    The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable).

  7. Number of Participants who used Healthcare Resource Utilization (HRU)

    Time frame: Up to approximately 6 months

    HRU is measured from initiation of the studied line of therapy and captures .. eg physician visits, hospital stays and engagement with other supporting therapists.

  8. Number of Participants achieving monotherapy with Foslevodopa/Foscarbidopa (LDp/CDp)

    Time frame: Up to approximately 6 months

    Percentage of patients achieving monotherapy with LDp/CDp at month 3 and month 6

  9. Questionnaire to investigate the practicalities of the infusion system

    Time frame: Up to approximately 6 months

    Questionnaire to investigate the practicalities of the infusion system e.g., vial consumption, frequency of infusion-site rotation, nighttime dose adjustments) will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Bergmann

CONTACT

[email protected]

+49(0)170 4538568

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Global Real-World Evidence Study on the Effectiveness and Safety/Tolerability of Foslevodopa/Foscarbidopa in Patients Earlier Within Advanced Parkinson's Disease

Acronym: PUCCINI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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