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

Официальное название

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

Обзор

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

Первичные конечные точки

• Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV [Срок оценки: Up to approximately 6 months]

Вторичные конечные точки (11)

• Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Motor experiences of daily living as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Disease-specific sleep disturbances as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Symptom severity measured by the Patient Global Impression of Severity (PGI-S) [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Symptom severity measured by the Patient Global Impression of Change (PGI-C) [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Symptom severity measured by the Clinical Global Impression of Severity (CGI-S) scores [Срок оценки: Up to approximately 6 months]
• Change From Baseline in Symptom severity measured by the Clinical Global Impression of Change (CGI-C) scores [Срок оценки: Up to approximately 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Boston Medical Center Health System — Boston

Идентификаторы

NCT: NCT07227896 · P25-758

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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