Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease
Parkinson's Disease
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 69 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 100 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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 69 years of age
- Disease duration (time since diagnosis) \<10 years
- Time since motor fluctuations started ≤5 years
- H\&Y Stage \<3 in best "on"
- "off" time of ≤ 4.5 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.
Población del estudio
Participants with earlier within advanced Parkinson disease receiving Foslevodopa/Foscarbidopa treatment in accordance with the local label requirements in the participating country.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change From Baseline in motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore
Plazo: Up to approximately 6 months
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore is an investigator-used rating tool to assess the motor complications of Parkinson's Disease (PD). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)
Medidas secundarias
Change From Baseline to "Off" Time Duration (absolute hours) and Severity, as measured by the modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Item 4.3 and 4.4 scores
Plazo: Up to approximately 6 months
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore is an investigator-used rating tool to assess the motor complications of Parkinson's Disease (PD). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)
Change From Baseline in Dyskinesia presence, impairment and disability, as measured by Unified Dyskinesia Rating Scale (UDysRS) total score
Plazo: Up to approximately 6 months
The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.
Change From Baseline in Dyskinesia duration (absolute hours) and severity, as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV, Item 4.1 and 4.2 score
Plazo: Up to approximately 6 months
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore is an investigator-used rating tool to assess the motor complications 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
Plazo: 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)
Plazo: 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)
Plazo: 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
Plazo: 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) questionnaire.
Plazo: 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 Clinician-Reported Symptom Severity measured by the Clinical Global Impression of Severity (CGI-S) questionnaire.
Plazo: Up to approximately 6 months
Clinical Global Impression of Severity (CGI-S) is a 5-point rating scale that requires the clinician to assess the severity of the participant's illness. Scores range from 1=normal; to 5=very severe.
Change From Baseline in Patient-Reported Symptom Change measured by the Patient Global Impression of Change (PGI-C) questionnaire
Plazo: Up to approximately 6 months
The PGI-C is a participant's rating of the change in their PD-related symptoms since initiation of study drug. Participants rate their change in status using the following 7-point scale: 1 = Very much improved; 7 = Very much worse.
Change From Baseline in Clinician-Reported Symptom Change measured by the Clinical Global Impression of Change (CGI-C) questionnaire.
Plazo: 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.
Otras medidas
Change From Baseline in morning akinesia (early morning "off") as measured by by dedicated questionnaire.
Plazo: Up to approximately 6 months
Measured by dedicated questionnaire.
Change From Baseline in the Presence and Frequency of Early Morning Dystonia, as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) single item 12
Plazo: 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 Activities of daily living/independence as measured by the Schwab-England Activities of Daily Living (SE-ADL) Scale
Plazo: Up to approximately 6 months
The Schwab and England ADL (Activities of Daily Living) scale assesses the capabilities of people with impaired mobility. The scale uses percentages to reflect the effort and dependence on others people that are needed to complete daily chores." The results reported are between 0% (bedridden) and 100% (healthy).
Change From Baseline in Self-efficacy as measured by the Self-efficacy for Managing Chronic Disease Scale (SEMCD)
Plazo: Up to approximately 6 months
Self-efficacy for Managing Chronic Disease Scale (SEMCD) Self-efficacy for chronic disease will be measured. 6 items 1 to 10 each. 1 = not confident 10 = total confident.
Change From Baseline in Ability to Reintegrate Into Normal Social Activity After Illness as measured by the Reintegration to Normal Living Scale (RNLI) Scale
Plazo: Up to approximately 6 months
The Reintegration to Normal Living Index (RNLI) assesses how well individuals resume everyday activities and participate in their communities following illness or injury. It covers areas such as mobility, daily functioning, and self-perception, and includes 11 items scored on a 0-10 scale, with higher scores indicating greater reintegration into normal living.
Change From Baseline in Treatment satisfaction, as measured by the Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score (TSQM-9)
Plazo: Up to approximately 6 months
Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score. an instrument used to measure how satisfied adult patients are with their medications. The scale consists of 9 items with 5 or 7 Likert scale answering options.
Change From Baseline in Stigma as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index
Plazo: 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).
Healthcare Resource Utilization (HRU)
Plazo: Up to approximately 6 months
Healthcare Resource Utilization (HRU) is measured from initiation of the therapy and captures eg physician visits, hospital stays and engagement with other supporting therapists.
Number of Participants achieving monotherapy with Foslevodopa/Foscarbidopa (LDp/CDp)
Plazo: Up to approximately 6 months
Percentage of patients achieving monotherapy with LDp/CDp at month 3 and month 6
Questionnaire to investigate the practicalities of the infusion system
Plazo: 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).
Number of Participants with Adverse Events (AEs)
Plazo: Up to approximately 6 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (26)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
26 centros
Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277190Boca Raton, Florida, United StatesReclutando
University of South Florida- Neuroscience Institute /ID# 278562Tampa, Florida, United StatesReclutando
Novant Health /ID# 278567Charlotte, North Carolina, United StatesReclutando
Texas Movement Disorder Specialists /ID# 278565Georgetown, Texas, United StatesReclutando
Toronto Western Hospital /ID# 278384Toronto, Ontario, CanadaReclutando
CIUSSS de l Estrie - CHUS /ID# 278379Sherbrooke, Quebec, CanadaReclutando
Klinicka Bolnica Dubrava /ID# 278408Grad Zagreb, City of Zagreb, CroatiaReclutando
Klinicki Bolnicki Centar Rijeka /ID# 278277Rijeka, Primorje-Gorski Kotar County, CroatiaReclutando
Shaare Zedek Medical Center /ID# 276209Jerusalem, Jerusalem, IsraelReclutando
The Chaim Sheba Medical Center /ID# 276210Ramat Gan, Tel Aviv, IsraelReclutando
Tel Aviv Sourasky Medical Center /ID# 276212Tel Aviv, Tel Aviv, IsraelReclutando
Hadassah Medical Center-Hebrew University /ID# 276211Jerusalem, IsraelReclutando
Saitama Medical University Hospital /ID# 280624Iruma-gun, Saitama, JapanReclutando
Juntendo University Hospital /ID# 280623Bunkyo-ku, Tokyo, JapanReclutando
Noge General Medicine and Neurology /ID# 280741Kanagawa, JapanReclutando
Itsuki Hospital /ID# 280743Tokushima, JapanReclutando
Miwa Internal Medicine Clinic /ID# 280740Tokyo, JapanReclutando
Centro Internacional De Mercadeo /ID# 276088Guaynabo, Puerto RicoReclutando
Fundeni Clinical Institute /ID# 277490Bucharest, Bucharest, RomaniaReclutando
Arcadia Spitale Si Centre Medicale /Id# 277525Iași, Iaşi, RomaniaReclutando
Neurotim Med /ID# 277500Timișoara, Timiș County, RomaniaReclutando
Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499Brasov, RomaniaReclutando
Hospital de Sant Joan Despi Moises Broggi /ID# 276895Sant Joan Despí, Barcelona, SpainReclutando
University Hospitals Plymouth NHS Trust /ID# 284977Plymouth, Devon, United KingdomReclutando
Charing Cross Hospital /ID# 284211London, Hammersmith and Fulham, United KingdomReclutando
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 281752Newcastle upon Tyne, United KingdomReclutando
Equipo y fechas
- Patrocinador principal
- AbbVie
- Inicio del estudio
- 3 ago 2026 Real
- Finalización primaria
- 2027-10 Estimado
- Finalización del estudio
- 2027-10 Estimado
- Primera publicación
- 13 nov 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Global Real-World Evidence Study on the Effectiveness and Safety/Tolerability of Foslevodopa/Foscarbidopa in Patients Earlier Within Advanced Parkinson's Disease
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026