NCT07227896Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 10 Nov 2025
- Start date
- 3 Aug 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- AbbVie
- Diseases
- Parkinson disease
- NCT number
- NCT07227896
What you commit to
- Study type: Observational
- Planned participants: 100
- From 3 Aug 2026 to the primary completion date, Oct 2027
- 10 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Participation in a concurrent investigational or observational clinical trial
Other illness
- History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country
- 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.
Other
- Mini-Mental State Examination (MMSE) score \<24
- Lack of motivation/insufficient language skills to complete the study questionnaires
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Plymouth NHS Trust /ID# 284977 Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| Shaare Zedek Medical Center /ID# 276209 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 276211 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 276210 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 276212 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499 Coordinator of this site? Confirm its status | Brasov | Romania | Not yet recruiting |
| Fundeni Clinical Institute /ID# 277490 Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Arcadia Spitale Si Centre Medicale /Id# 277525 Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Neurotim Med /ID# 277500 Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Texas Movement Disorder Specialists /ID# 278565 Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.