Clinical trial NCT06916507: Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Foscarbidopa/Foslevodopa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced Parkinson's disease with time since the beginning of motor fluctuations ≤3 years and the Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in OFF Time (hours)
timeFrame: Up To 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
state: Baden-Wuerttemberg
city: Wolfach
country: Germany
facility: Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
state: Baden-Wuerttemberg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167
state: Sachsen
city: Gera
country: Germany
facility: Praxis MD Oehlwein /ID# 274222
state: Thueringen
city: Stadtroda
country: Germany
facility: Asklepios Fachklinikum Stadtroda /ID# 274162
state: Thueringen
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: