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

NCT07284342 | Recruiting

• 1 other identifier: P25-423
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Advanced Parkinson's Disease

Keywords

Advanced Parkinson's Disease; Foslevodopa/Foscarbidopa

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Study Arms (1)

Foslevodopa/Foscarbidopa

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (14)

Hospital Regional Universitario de Malaga /ID# 276357

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitari Son Espases /ID# 276349

Palma, Balearic Islands, 07120, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla /ID# 276315

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital General Universitario Santa Lucía /ID# 277222

Cartagena, Murcia, 30202, Spain

RECRUITING

Hospital de Cabuenes /ID# 276314

Gijón, Principality of Asturias, 33394, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 277806

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitario Torrecárdenas /ID# 276899

Almería, 04009, Spain

RECRUITING

Hospital Universitario Vall de Hebron /ID# 276318

Barcelona, 08035, Spain

RECRUITING

Hospital Santa Creu i Sant Pau /ID# 276319

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario De Burgos /ID# 276317

Burgos, 09006, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves /ID# 276350

Granada, 18014, Spain

RECRUITING

Hospital Universitario Clinico San Cecilio /ID# 276356

Granada, 18016, Spain

RECRUITING

Complejo Hospitalario Universitario de Pontevedra /ID# 276313

Pontevedra, 36071, Spain

RECRUITING

Hospital Universitario De Toledo /ID# 276884

Toledo, 45007, Spain

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

AbbVie Spain

CONTACT

+34913840910; estudios.spain@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (14)