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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician."
  • "Participants will be followed for up to 6 months."
Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how well foslevodopa/foscarbidopa works and affects quality of life in adults earlier in advanced Parkinson's disease. It follows people ages 18–80 whose doctors have already chosen this treatment, given through an infusion under the skin. Follow-up lasts up to 6 months, with questionnaires but no extra study exams.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18–80 and have Parkinson's disease with no known cause that improves with levodopa.
  • Were diagnosed less than 10 years ago, and have had changes in how well movement symptoms are controlled for no more than 3 years.
  • Have a Hoehn and Yahr score below 3 when medicine works best. This score measures how severe Parkinson's symptoms are.
  • Have 2.5–6 hours each day of “off” time, when medicine does not control symptoms well.
  • Have never used foslevodopa/foscarbidopa and meet local rules for receiving it, including payment rules if needed.
  • Your doctor believes your pills or skin patches have been adjusted for the best effect and chose this treatment before inviting you to the study.
  • Are willing and able to follow study steps, including entering information and answering questionnaires on a tablet.
  • You or your legal representative sign the required consent and data-use forms before study steps begin, after the study is explained and questions are answered.

Who can't join

  • Have a condition that makes foslevodopa/foscarbidopa unsafe under the approved local drug instructions.
  • Have ever used device-assisted Parkinson's treatment, such as deep brain stimulation, an apomorphine pump under the skin, or levodopa medicine delivered into the gut.
  • Score below 24 on the Mini-Mental State Examination, a test of memory and thinking.
  • Are taking part in another clinical study, including one that only observes your health.
  • Do not feel willing to complete the questionnaires or cannot use the language needed to answer them.
  • Have a history of major skin problems, such as psoriasis or eczema. Other skin changes, such as sunburn, wounds, acne, scars, or tattoos, may also rule you out if the study doctor thinks they could affect the infusion or study checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX