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Parkinson's sleep breakthrough? new infusion under study

NCT ID NCT07284342

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study looks at whether a new pump-delivered medication (Foslevodopa/Foscarbidopa) can help improve sleep problems in people with advanced Parkinson's disease. About 103 adults in Spain will take part, and researchers will track their sleep quality over 12 weeks using a simple questionnaire. The goal is to see if this already-approved treatment makes a real difference in nighttime rest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de Pontevedra /ID# 276313

    RECRUITING

    Pontevedra, 36071, Spain

  • Hospital De Santa Caterina /ID# 280913

    RECRUITING

    Girona, 17190, Spain

  • Hospital General Universitario Santa Lucia /ID# 277222

    RECRUITING

    Cartagena, Murcia, 30202, Spain

  • Hospital Germans Trias i Pujol /ID# 280865

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Regional Universitario de Malaga /ID# 276357

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Santa Creu i Sant Pau /ID# 276319

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital Universitari Son Espases /ID# 276349

    RECRUITING

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitario Clinico San Cecilio /ID# 276356

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario De Burgos /ID# 276317

    RECRUITING

    Burgos, 09006, Spain

  • Hospital Universitario De Toledo /ID# 276884

    RECRUITING

    Toledo, 45007, Spain

  • Hospital Universitario Marques de Valdecilla /ID# 276315

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Torrecardenas /ID# 276899

    RECRUITING

    Almería, 04009, Spain

  • Hospital Universitario Vall de Hebron /ID# 276318

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de las Nieves /ID# 276350

    RECRUITING

    Granada, 18014, Spain

  • Hospital Universitario Virgen del Rocio /ID# 277806

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Hospital de Cabuenes /ID# 276314

    RECRUITING

    Gijón, Principality of Asturias, 33394, Spain

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