Parkinson's Trial NCT07284342
Improve sleep with skin infusion
- Trial ID
- NCT07284342
- Official Title
- Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
- Goal
- Improve sleep with skin infusion
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 103 participants
- Conditions
- Advanced Parkinson's Disease
Summary For Families
The study is checking whether giving Foslevodopa/Foscarbidopa as a continuous under-the-skin infusion can change sleep problems in adults with advanced Parkinson's disease, which can include tremors, stiffness, and slowed movement. Participants will get the approved medication as their doctor prescribes and be followed for up to 12 weeks during their usual clinic visits, so no extra tests or visits are expected. About 103 adults at around 20 sites in Spain will join; to be eligible you must be 18 or older, have advanced Parkinson's that responds to levodopa, and already have the infusion prescribed by your clinician. You also need a basic memory score of 24 or higher to follow study steps; people with medical reasons not to use the medicine or who are in other interventional trials cannot join, and those with moderate to severe sleep apnea may be allowed only if they use a breathing machine at night (continuous positive airway pressure) or a prescribed mouth device.
Locations
- Hospital Regional Universitario de Malaga /ID# 276357, Málaga, Andalusia, Spain
- Hospital Universitari Son Espases /ID# 276349, Palma, Balearic Islands, Spain
- Hospital Germans Trias i Pujol /ID# 280865, Badalona, Barcelona, Spain
- Hospital Universitario Marques de Valdecilla /ID# 276315, Santander, Cantabria, Spain
- Hospital General Universitario Santa Lucía /ID# 277222, Cartagena, Murcia, Spain
- Hospital de Cabuenes /ID# 276314, Gijón, Principality of Asturias, Spain
- Hospital Universitario Virgen del Rocio /ID# 277806, Seville, Sevilla, Spain
- Hospital Universitario Torrecárdenas /ID# 276899, Almería, Spain
- Hospital Universitario Vall de Hebron /ID# 276318, Barcelona, Spain
- Hospital Santa Creu i Sant Pau /ID# 276319, Barcelona, Spain
- Hospital Universitario De Burgos /ID# 276317, Burgos, Spain
- Hospital De Santa Caterina /ID# 280913, Girona, Spain
- Hospital Universitario Virgen de las Nieves /ID# 276350, Granada, Spain
- Hospital Universitario Clinico San Cecilio /ID# 276356, Granada, Spain
- Complejo Hospitalario Universitario de Pontevedra /ID# 276313, Pontevedra, Spain
- Hospital Universitario De Toledo /ID# 276884, Toledo, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The study is checking whether giving Foslevodopa/Foscarbidopa as a continuous under-the-skin infusion can change sleep problems in adults with advanced Parkinson's disease, which can include tremors, stiffness, and slowed movement. Participants will get the approved medication as their doctor prescribes and be followed for up to 12 weeks during their usual clinic visits, so no extra tests or visits are expected. About 103 adults at around 20 sites in Spain will join; to be eligible you must be 18 or older, have advanced Parkinson's that responds to levodopa, and already have the infusion prescribed by your clinician. You also need a basic memory score of 24 or higher to follow study steps; people with medical reasons not to use the medicine or who are in other interventional trials cannot join, and those with moderate to severe sleep apnea may be allowed only if they use a breathing machine at night (continuous positive airway pressure) or a prescribed mouth device.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 16 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 1 year and 1 month.
- 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.
- How many visits does this trial involve?
- Participants will attend regular visits during the study at a hospital or clinic and will be followed for up to 12 weeks.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive); Intravenous infusion (minimally invasive). Confirm the full schedule with the study coordinator.