Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)

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 foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Heidelberg /ID# 274164, Heidelberg, Baden-Wurttemberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
Participant must be an adult male or female, 18-64 years of age
Time since beginning of motor fluctuations ≤ 3 years
The Hoehn and Yahr (H&Y) stage < 3 in the on-medication condition
Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study

Exclusion criteria

Previous Exposure to any device-aided therapy (DAT).
Any condition included in the contraindications section of the approved local LDp/CDp label.
Participants with Mini mental state examination (MMSE) score < 24

Treatment and study plan

Primary outcomes

Change From Baseline in OFF Time (hours)

Time frame: Up To 12 months

The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information Germany

CONTACT

[email protected]

49 611 1720 1520

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Apr 8, 2025
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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