Boston Medical Center Health System
Boston, Massachusetts, 02118, United States
NCT Number: NCT07227896
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
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Boston, Massachusetts, 02118, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
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).
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)
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).
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.
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.
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]).
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.
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.
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.
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.
Time frame: Up to approximately 6 months
Measured by dedicated questionnaire.
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.
Time frame: Up to approximately 6 months
Self-efficacy for Managing Chronic Disease Scale (SEMCD) Self-efficacy for chronic disease will be measured.
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
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).
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).
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.
Time frame: Up to approximately 6 months
Percentage of patients achieving monotherapy with LDp/CDp at month 3 and month 6
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
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
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
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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