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
Plain-Language Summary
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.