Status:
RECRUITING
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
Lead Sponsor:
AbbVie
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-64 years
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 tremor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06916507
Start Date
May 6 2025
End Date
September 1 2027
Last Update
September 8 2025
Active Locations (13)
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1
Universitaetsklinikum Heidelberg /ID# 274164
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Universitaetsklinikum Tuebingen /ID# 275828
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
Ulm, Baden-Wurttemberg, Germany, 89073
4
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
Wolfach, Baden-Wurttemberg, Germany, 77709