Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease
- Conditions
- Parkinson's Disease
- Registration Number
- NCT07227896
- Lead Sponsor
- AbbVie
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV 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 Outcome Measures
Name Time Method Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV 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)
Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV 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).
Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV 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)
Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index 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).
Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) 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.
Change From Baseline in Motor experiences of daily living as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 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.
Change From Baseline in Disease-specific sleep disturbances as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score 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 \[never\]).
Change From Baseline in Symptom severity measured by the Patient Global Impression of Severity (PGI-S) 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.
Change From Baseline in Symptom severity measured by the Patient Global Impression of Change (PGI-C) 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.
Change From Baseline in Symptom severity measured by the Clinical Global Impression of Severity (CGI-S) scores 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.
Change From Baseline in Symptom severity measured by the Clinical Global Impression of Change (CGI-C) scores 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.
Trial Locations
- Locations (1)
Boston Medical Center Health System
🇺🇸Boston, Massachusetts, United States
Boston Medical Center Health System🇺🇸Boston, Massachusetts, United States