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

Not yet recruiting

• Conditions: Parkinson's Disease

• Registration Number: NCT06916507
• Lead Sponsor: AbbVie

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-30
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in OFF Time (hours)	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).

Trial Locations

Locations (1)

Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161; 🇩🇪 Wolfach, Baden-Wuerttemberg, Germany