Parkinson's Trial NCT06916507
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
Summary For Families
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
- Universitaetsklinikum Erlangen /ID# 280831, Erlangen, Bavaria, Germany
- Klinikum Ingolstadt /ID# 280573, Ingolstadt, Bavaria, 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
- Klinikum Lippe Detmold /ID# 279451, Detmold, North Rhine-Westphalia, Germany
- Klinikum Dortmund Klinikzentrum Mitte /ID# 280222, Dortmund, North Rhine-Westphalia, Germany
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167, Dresden, Saxony, Germany
- Krankenhaus Martha-Maria Halle-Dolau /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 17 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.