Continuous medication reduces motor fluctuations
- Trial ID
- NCT06916507
- 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
- Goal
- Continuous medication reduces motor fluctuations
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 125 participants
- Conditions
- Parkinson's Disease
Plain-Language Summary
The goal is to see whether starting foslevodopa/foscarbidopa early in the advanced phase can improve motor symptoms, quality of life, psychosocial functioning and ability to work in routine clinical care. Foslevodopa/foscarbidopa is a prodrug that converts to levodopa and carbidopa and is given as a continuous formulation to keep steadier levodopa levels, which can reduce wearing-off and motor fluctuations that happen with intermittent oral levodopa and may alter oral dosing needs. The study is enrolling adults 18 to 64 with levodopa-responsive idiopathic Parkinson's, motor fluctuations for three years or less, Hoehn and Yahr stage under 3 on medication, MMSE 24 or higher, no prior device-aided therapy, and a clinician who has already decided to start LDp/CDp.
Locations
- Universitaetsklinikum Heidelberg /ID# 274164, Heidelberg, Baden-Wurttemberg, Germany
- Universitaetsklinikum Tuebingen /ID# 275828, Tübingen, Baden-Wurttemberg, Germany
- Praxis Prof. Kassubek/Prof. Riecker /ID# 274165, Ulm, Baden-Wurttemberg, Germany
- Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161, Wolfach, Baden-Wurttemberg, Germany
- Klinikum der Universitaet Muenchen Grosshadern /ID# 274168, Munich, Bavaria, Germany
- Klinikum Ernst von Bergmann /ID# 274176, Potsdam, Brandenburg, Germany
- Universitaetskliniken Giessen und Marburg /ID# 274224, Marburg, Hesse, Germany
- Knappschaftskrankenhaus Bottrop /ID# 274284, Bottrop, North Rhine-Westphalia, Germany
- Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865, Cologne, North Rhine-Westphalia, Germany
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167, Dresden, Saxony, Germany
- Krankenhaus Martha-Maria Halle-Dölau /ID# 274174, Halle, Saxony-Anhalt, Germany
- Praxis MD Oehlwein /ID# 274222, Gera, Thuringia, Germany
- Asklepios Fachklinikum Stadtroda /ID# 274162, Stadtroda, Thuringia, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether starting foslevodopa/foscarbidopa early in the advanced phase can improve motor symptoms, quality of life, psychosocial functioning and ability to work in routine clinical care. Foslevodopa/foscarbidopa is a prodrug that converts to levodopa and carbidopa and is given as a continuous formulation to keep steadier levodopa levels, which can reduce wearing-off and motor fluctuations that happen with intermittent oral levodopa and may alter oral dosing needs. The study is enrolling adults 18 to 64 with levodopa-responsive idiopathic Parkinson's, motor fluctuations for three years or less, Hoehn and Yahr stage under 3 on medication, MMSE 24 or higher, no prior device-aided therapy, and a clinician who has already decided to start LDp/CDp.
- Who can participate?
- Participants must be between 18 Years and 64 Years.
- Where is this trial located?
- This trial is recruiting at 13 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.