Recruiting

Foslevodopa/Foscarbidopa

Sponsor:

AbbVie

Code:

NCT07227896

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Parkinson's Disease

Study ID

NCT07227896

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Foslevodopa/Foscarbidopa

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lars Bergmann

+49(0)170 4538568lars.bergmann@abbvie.com

Locations

Texas Movement Disorder Specialists /ID# 278565

Recruiting

Georgetown, Texas, United States, 78628

More Information

Sponsor

AbbVie

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Parkinson's Disease
  • Foslevodopa/Foscarbidopa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.