Parkinson's Trial NCT06937034
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?
- 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 8 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.