A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa (ONIROS)

April 9, 2026 updated by: AbbVie

Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess change in sleep disturbances of adult participants with advanced Parkinson's disease receiving subcutaneous Foslevodopa/Foscarbidopa under routine clinical practice.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 103 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites across Spain.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 weekss.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Almería, Spain, 04009
        • Recruiting
        • Hospital Universitario Torrecárdenas /ID# 276899
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall de Hebron /ID# 276318
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Santa Creu i Sant Pau /ID# 276319
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario De Burgos /ID# 276317
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves /ID# 276350
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario Clinico San Cecilio /ID# 276356
      • Pontevedra, Spain, 36071
        • Recruiting
        • Complejo Hospitalario Universitario de Pontevedra /ID# 276313
      • Toledo, Spain, 45007
        • Recruiting
        • Hospital Universitario De Toledo /ID# 276884
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga /ID# 276357
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases /ID# 276349
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla /ID# 276315
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Recruiting
        • Hospital General Universitario Santa Lucía /ID# 277222
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain, 33394
        • Recruiting
        • Hospital de Cabuenes /ID# 276314
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio /ID# 277806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with advanced Parkinson's disease receiving subcutaneous infusion of Foslevodopa/Foscarbidopa as prescribed by their physician.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on Parkinson's Disease (PD)-related sleep disturbances in Advance Parkinson's Disease (aPD) Participants, as assessed by the Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Time Frame: Up to approximately 12 weeks
The Parkinson's Disease Sleep Scale (PDSS-2) is a self-administered questionnaire and consists of 15 questions on sleep and nocturnal disturbances which can be related to PD. Participants rate each question using a frequency score, ranging from 0 (never) to 4 (very often), the PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
Up to approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P25-423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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