Real-world look at Foslevodopa/Foscarbidopa for people with early advanced Parkinson’s

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study of Foslevodopa/Foscarbidopa given by doctors in typical clinical practice. About 100 adults with Parkinson’s disease will be enrolled across roughly 40 sites globally and followed for up to 6 months. Participants complete several questionnaires to track motor function and quality of life without extra tests beyond standard care. The study relies on real-world use rather than a controlled clinical trial setting. No additional procedures are mandated beyond data entry and questionnaires.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277190
  Boca Raton, Florida, United States Recruiting
• University of South Florida- Neuroscience Institute /ID# 278562
  Tampa, Florida, United States Recruiting
• Novant Health /ID# 278567
  Charlotte, North Carolina, United States Recruiting
• Texas Movement Disorder Specialists /ID# 278565
  Georgetown, Texas, United States Recruiting
• Toronto Western Hospital /ID# 278384
  Toronto, Ontario, Canada Recruiting
• CIUSSS de l Estrie - CHUS /ID# 278379
  Sherbrooke, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Lars Bergmann
• Email: lars.bergmann@abbvie.com
• Phone: +49(0)170 4538568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ginger as a Modifier of Ghrelin Levels in Parkinson’s Disease and REM Sleep Behavior Disorder

  This study tests whether ginger capsules can raise ghrelin levels in people with Parkinson’s disease, REM sleep behavior disorder, and healthy controls.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge · NCT07882108

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Mental imagery with self-regulation to help daily activities in Parkinson's disease

  This study tests whether a six-week program of mental imagery combined with self-regulation can help people with Parkinson’s perform daily activities better than standard learning or exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07860294

• Real-world experiences of Inbrija for Parkinson's OFF episodes

  This study looks at how people with Parkinson’s who use Inbrija for OFF episodes feel and function in daily life.

  Recruiting Merz Pharmaceuticals GmbH · Altmünster and 1 other locations · NCT07797790

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Test of RO7568282 in early Parkinson's disease

  This study tests whether RO7568282, compared with placebo, is safe and helps people with early Parkinson's disease who are already taking levodopa.

  Recruiting at 4 sites Phase 2 Hoffmann-La Roche · Boca Raton, Florida and 3 other locations · NCT07781644

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.