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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.