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

Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Knappschaftskrankenhaus Bottrop /ID# 274284
RECRUITING
Bottrop
Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865
NOT_YET_RECRUITING
Cologne
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167
RECRUITING
Dresden
Praxis MD Oehlwein /ID# 274222
RECRUITING
Gera
Krankenhaus Martha-Maria Halle-Dölau /ID# 274174
RECRUITING
Halle
Universitaetsklinikum Heidelberg /ID# 274164
RECRUITING
Heidelberg
Universitaetskliniken Giessen und Marburg /ID# 274224
RECRUITING
Marburg
Klinikum der Universitaet Muenchen Grosshadern /ID# 274168
NOT_YET_RECRUITING
Munich
Klinikum Ernst von Bergmann /ID# 274176
RECRUITING
Potsdam
Asklepios Fachklinikum Stadtroda /ID# 274162
RECRUITING
Stadtroda
Universitaetsklinikum Tuebingen /ID# 275828
RECRUITING
Tübingen
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
RECRUITING
Ulm
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
RECRUITING
Wolfach
Contact Information
Primary
Medical Information Germany
medinfo.germany@abbvie.com
49 611 1720 1520
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2027-09
Participants
Target number of participants: 125
Treatments
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov