Steady medication infusion improves sleep
- Trial ID
- NCT07284342
- Official Title
- Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
- Goal
- Steady medication infusion improves sleep
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 103 participants
- Conditions
- Advanced Parkinson's Disease
Summary For Families
The goal is to see whether using a continuous subcutaneous infusion of foslevodopa/foscarbidopa can improve sleep disturbances in people with advanced, levodopa-responsive Parkinson’s, especially when severe motor fluctuations or dyskinesia have not been controlled by other meds. The treatment delivers levodopa plus a decarboxylase inhibitor as a steady subcutaneous infusion, keeping blood levodopa levels more constant than oral doses and potentially reducing nighttime motor symptoms and sleep fragmentation. Adults 18 and older with advanced idiopathic Parkinson’s who have been started on the subcutaneous infusion by their clinician and can follow study procedures (MMSE 24 or higher) are eligible. People with treated moderate to severe sleep apnea may join if their CPAP or dental device use is adequate and their recent apnea index is under 15, while anyone with contraindications in the product information or enrolled in another interventional trial is excluded.
Locations
- Hospital Regional Universitario de Malaga /ID# 276357, Málaga, Andalusia, Spain
- Hospital Universitari Son Espases /ID# 276349, Palma, Balearic Islands, 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 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 goal is to see whether using a continuous subcutaneous infusion of foslevodopa/foscarbidopa can improve sleep disturbances in people with advanced, levodopa-responsive Parkinson’s, especially when severe motor fluctuations or dyskinesia have not been controlled by other meds. The treatment delivers levodopa plus a decarboxylase inhibitor as a steady subcutaneous infusion, keeping blood levodopa levels more constant than oral doses and potentially reducing nighttime motor symptoms and sleep fragmentation. Adults 18 and older with advanced idiopathic Parkinson’s who have been started on the subcutaneous infusion by their clinician and can follow study procedures (MMSE 24 or higher) are eligible. People with treated moderate to severe sleep apnea may join if their CPAP or dental device use is adequate and their recent apnea index is under 15, while anyone with contraindications in the product information or enrolled in another interventional trial is excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 14 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 1 year and 1 month.
- 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.