A Study to Assess Change in Sleep Disturbances of Adult P... | NCT07284342

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Nov 21, 2025

First Submission Date that Met QC Criteria

Dec 2, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Estimated

Label	Type	Description	Intervention Names
Foslevodopa/Foscarbidopa		Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Outcomes Module

Primary Outcomes

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)	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
AbbVie Spain	Contact	+34913840910		estudios.spain@abbvie.com

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Regional Universitario de Malaga /ID# 276357	Recruiting	Málaga	Andalusia	29010	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided