---
title: Steady medication infusion improves sleep
nct_id: NCT07284342
status: RECRUITING
sponsor: AbbVie
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07284342"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07284342"
last_fetched: "2026-05-10T14:07:29.016Z"
source: "Parkinson's Pathways (curated)"
---
# Steady medication infusion improves sleep

**Goal (in five words):** Steady medication infusion improves sleep

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

**Trial ID:** [NCT07284342](https://clinicaltrials.gov/study/NCT07284342)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** AbbVie
- **Target Enrollment:** 103 participants
- **Start Date:** 2025-11-17
- **Completion Date:** 2027-01
- **Conditions:** Advanced Parkinson's Disease

## Summary For Families

The goal is to see whether using a continuous subcutaneous infusion of foslevodopa/foscarbidopa can improve sleep disturbances in people with advanced, levodopa-responsive Parkinson’s, especially when severe motor fluctuations or dyskinesia have not been controlled by other meds. The treatment delivers levodopa plus a decarboxylase inhibitor as a steady subcutaneous infusion, keeping blood levodopa levels more constant than oral doses and potentially reducing nighttime motor symptoms and sleep fragmentation. Adults 18 and older with advanced idiopathic Parkinson’s who have been started on the subcutaneous infusion by their clinician and can follow study procedures (MMSE 24 or higher) are eligible. People with treated moderate to severe sleep apnea may join if their CPAP or dental device use is adequate and their recent apnea index is under 15, while anyone with contraindications in the product information or enrolled in another interventional trial is excluded.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full 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.
```

## Locations (14)

- Hospital Regional Universitario de Malaga /ID# 276357, Málaga, Andalusia, Spain _(36.7202, -4.4203)_
- Hospital Universitari Son Espases /ID# 276349, Palma, Balearic Islands, Spain _(39.5694, 2.6502)_
- Hospital Universitario Marques de Valdecilla /ID# 276315, Santander, Cantabria, Spain _(43.4659, -3.8049)_
- Hospital General Universitario Santa Lucía /ID# 277222, Cartagena, Murcia, Spain _(37.6020, -0.9840)_
- Hospital de Cabuenes /ID# 276314, Gijón, Principality of Asturias, Spain _(43.5357, -5.6615)_
- Hospital Universitario Virgen del Rocio /ID# 277806, Seville, Sevilla, Spain _(37.3828, -5.9732)_
- Hospital Universitario Torrecárdenas /ID# 276899, Almería, Spain _(36.8381, -2.4597)_
- Hospital Universitario Vall de Hebron /ID# 276318, Barcelona, Spain _(41.3888, 2.1590)_
- Hospital Santa Creu i Sant Pau /ID# 276319, Barcelona, Spain _(41.3888, 2.1590)_
- Hospital Universitario De Burgos /ID# 276317, Burgos, Spain _(42.3411, -3.7018)_
- Hospital Universitario Virgen de las Nieves /ID# 276350, Granada, Spain _(37.1882, -3.6067)_
- Hospital Universitario Clinico San Cecilio /ID# 276356, Granada, Spain _(37.1882, -3.6067)_
- Complejo Hospitalario Universitario de Pontevedra /ID# 276313, Pontevedra, Spain _(42.4310, -8.6443)_
- Hospital Universitario De Toledo /ID# 276884, Toledo, Spain _(39.8581, -4.0226)_

## Central Contacts

- AbbVie Spain — (CONTACT) — +34913840910 — estudios.spain@abbvie.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07284342*  
*HTML version: https://parkinsonspathways.com/trial/NCT07284342*  
*Source data: https://clinicaltrials.gov/study/NCT07284342*