Sleep changes in adults with advanced Parkinson's taking subcutaneous foslevodopa/foscarbidopa.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Regional Universitario de Malaga /ID# 276357
  Málaga, Andalusia, Spain Recruiting
• Hospital Universitari Son Espases /ID# 276349
  Palma, Balearic Islands, Spain Recruiting
• Hospital Germans Trias i Pujol /ID# 280865
  Badalona, Barcelona, Spain Recruiting
• Hospital Universitario Marques de Valdecilla /ID# 276315
  Santander, Cantabria, Spain Recruiting
• Hospital General Universitario Santa Lucia /ID# 277222
  Cartagena, Murcia, Spain Recruiting
• Hospital de Cabuenes /ID# 276314
  Gijón, Principality of Asturias, Spain Recruiting

Study contacts

• Study coordinator: AbbVie Spain
• Email: estudios.spain@abbvie.com
• Phone: +34913840910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.