ONIROS · P25-423

This observational study evaluates the effectiveness of a subcutaneous LDp/CDp solution administered via infusion in treating sleep disturbances in patients with advanced Parkinson’s disease.

Observational study evaluating the effectiveness of subcutaneous levodopa/prodrug carbidopa solution for infusion (LDp/CDp) on sleep disturbances in advanced Parkinson's disease.

Sponsor: ABBVIE

Phase: IV

Status: Recruiting

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Public study eligibility criteria

Inclusion

  • * 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

  • * 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.