Sleep changes in adults with advanced Parkinson's taking subcutaneous foslevodopa/foscarbidopa.
Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
This will see if subcutaneous foslevodopa/foscarbidopa improves sleep disturbances in adults with advanced Parkinson's disease who are prescribed the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 14 sites (Málaga, Andalusia and 13 other locations) |
| Trial ID | NCT07284342 on ClinicalTrials.gov |
What this trial studies
This observational study follows about 103 adults with advanced, levodopa-responsive Parkinson's disease who are prescribed subcutaneous foslevodopa/foscarbidopa during routine clinical care across roughly 20 sites in Spain. Participants will receive the medication as prescribed by their treating physicians and be followed for up to 12 weeks with clinic visits that align with usual care. Eligible participants must be age 18 or older and have an MMSE score ≥24, and those with treated moderate-to-severe obstructive sleep apnea may be included if compliant with CPAP. The study collects information on sleep disturbances without adding experimental procedures beyond standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced, levodopa-responsive Parkinson's disease who have been prescribed subcutaneous foslevodopa/foscarbidopa by their clinician, can complete study procedures (MMSE ≥24), and can attend clinic visits in the study regions in Spain.
Not a fit: Patients who are not prescribed the drug, have significant cognitive impairment (MMSE <24), have untreated severe sleep apnea, or cannot attend participating Spanish clinics are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could show that subcutaneous foslevodopa/foscarbidopa reduces sleep disturbances and improves nighttime sleep and daytime function for people with advanced Parkinson's disease.
How similar studies have performed: Previous clinical programs of subcutaneous levodopa/carbidopa formulations have shown benefits for motor fluctuations, but direct evidence specifically demonstrating sleep improvement is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age \>=18 years) Advance Parkinson's Disease (aPD) participants, diagnosed of levodopa-responsive idiopathic Symptoms PD (PD) prescribed on foslevodopa/foscarbidopa (LDp/CDp) Subcutaneous solution for infusion (SI) in routine clinical practice following approved Summary of product characteristics (SmPC) (levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results). * MMSE\>=24 (cognitive cut point for the subjects to be able to comply with study procedures). * Decision to treat with LDp/CDp SI made by the clinician prior to any decision to approach the subject to participate in this study. * Particpants with moderate to severe obstructive sleep apnea (OSA) (Apnea-Hypoapnea Index (AHI)\>15) may be eligible if they comply with treatment (Continuous Positive Airway Pressure (CPAP) device used at least 4 hours/night and 70% of the nights during last month or mandibular advancement device (MAD)) and have an AHI \<15. Exclusion Criteria: * Participants presenting with contraindications as per LDp/CDp SI SmPC. 2. * Participants participating in interventional research (not including non-interventional study, Post Marketing Observational Studies (PMOS), or registry participation) at time of enrollment visit.
Where this trial is running
Málaga, Andalusia and 13 other locations
- Hospital Regional Universitario de Malaga /ID# 276357 — Málaga, Andalusia, Spain (Recruiting)
- Hospital Universitari Son Espases /ID# 276349 — Palma, Balearic Islands, Spain (Recruiting)
- Hospital Universitario Marques de Valdecilla /ID# 276315 — Santander, Cantabria, Spain (Recruiting)
- Hospital General Universitario Santa Lucía /ID# 277222 — Cartagena, Murcia, Spain (Recruiting)
- Hospital de Cabuenes /ID# 276314 — Gijón, Principality of Asturias, Spain (Recruiting)
- Hospital Universitario Virgen del Rocio /ID# 277806 — Seville, Sevilla, Spain (Recruiting)
- Hospital Universitario Torrecárdenas /ID# 276899 — Almería, Spain (Recruiting)
- Hospital Universitario Vall de Hebron /ID# 276318 — Barcelona, Spain (Recruiting)
- Hospital Santa Creu i Sant Pau /ID# 276319 — Barcelona, Spain (Recruiting)
- Hospital Universitario De Burgos /ID# 276317 — Burgos, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves /ID# 276350 — Granada, Spain (Recruiting)
- Hospital Universitario Clinico San Cecilio /ID# 276356 — Granada, Spain (Recruiting)
- Complejo Hospitalario Universitario de Pontevedra /ID# 276313 — Pontevedra, Spain (Recruiting)
- Hospital Universitario De Toledo /ID# 276884 — Toledo, Spain (Recruiting)
Study contacts
- Study coordinator: AbbVie Spain
- Email: estudios.spain@abbvie.com
- Phone: +34913840910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.