Steady infusion reduces off periods
- Trial ID
- NCT06937034
- Official Title
- Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
- Goal
- Steady infusion reduces off periods
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 2000 participants
- Conditions
- Parkinson's Disease
Summary For Families
The goal is to collect real-world, practical experience with continuous subcutaneous foslevodopa/foscarbidopa for people with advanced Parkinson's who have troublesome motor fluctuations and off periods on oral levodopa. The work is a retrospective look at patients treated in routine care, and the medication consists of prodrugs that are converted into levodopa and carbidopa after infusion, delivering steady levodopa levels through a small pump to smooth on/off swings and often reduce the need for frequent oral levodopa doses. Eligible participants are adults 18 and older with levodopa-responsive idiopathic Parkinson's who were prescribed the LDp/CDp continuous subcutaneous infusion and enrolled in the AbbVie Patient Support Program.
Locations
- Medizinische Universitaet Graz /ID# 278569, Graz, Styria, Austria
- Medisch Spectrum Twente /ID# 276695, Enschede, Overijssel, Netherlands
- Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720, Timișoara, Timiș County, Romania
- Karolinska University Hospital Solna /ID# 277116, Solna, Stockholm County, Sweden
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to collect real-world, practical experience with continuous subcutaneous foslevodopa/foscarbidopa for people with advanced Parkinson's who have troublesome motor fluctuations and off periods on oral levodopa. The work is a retrospective look at patients treated in routine care, and the medication consists of prodrugs that are converted into levodopa and carbidopa after infusion, delivering steady levodopa levels through a small pump to smooth on/off swings and often reduce the need for frequent oral levodopa doses. Eligible participants are adults 18 and older with levodopa-responsive idiopathic Parkinson's who were prescribed the LDp/CDp continuous subcutaneous infusion and enrolled in the AbbVie Patient Support Program.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 4 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 8 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.