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Real-World check: can a new infusion drug ease advanced Parkinson's?

NCT ID NCT06965374

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 270 Italian adults with advanced Parkinson's disease who are already prescribed Foslevodopa/Foscarbidopa, a drug given as a continuous infusion under the skin. Researchers will track how the drug affects quality of life over 12 months using a standard questionnaire. The goal is to see how well the treatment works in real-world settings, outside of strict clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Foslevodopa/Foscarbidopa (a drug combination given as a continuous infusion under the skin)
What this could lead to
If successful, this study could confirm that Foslevodopa/Foscarbidopa improves daily life and symptom control for people with advanced Parkinson's in routine care.
What could go wrong
This is an observational, real-world study, not a controlled trial, so results may be less definitive. It is also limited to Italian participants, which may not apply to other populations.

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 270 people

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

Started

Jun 2025

Expected to finish

Jun 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

Participants with advanced Parkinson disease treated with Foslevodopa/Foscarbidopa according to label in Italy

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: * Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD) * Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study * 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies Exclusion Criteria: * Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label * Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable * History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson disease

How to take part

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

  1. The places running it

    19 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

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319

    RECRUITING

    Salerno, 84131, Italy

  • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949

    RECRUITING

    Milan, Milano, 20122, Italy

  • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388

    RECRUITING

    Reggio Emilia, 42122, Italy

  • Azienda Ospedale-Universita Padova /ID# 274317

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434

    RECRUITING

    Naples, Napoli, 80138, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863

    RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834

    RECRUITING

    Rome, Roma, 00133, Italy

  • Azienda Ospedaliero Universitaria Pisana /ID# 273541

    RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero Universitaria delle Marche /ID# 272694

    RECRUITING

    Ancona, 60020, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562

    RECRUITING

    Rome, Roma, 00161, Italy

  • Azienda Ulss 3 Serenissima /ID# 273027

    RECRUITING

    Venice, Venezia, 30100, Italy

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225

    RECRUITING

    Milan, Milano, 20133, Italy

  • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539

    RECRUITING

    Rome, Roma, 00168, Italy

  • IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628

    RECRUITING

    Messina, 98124, Italy

  • IRCCS Oasi SS. Troina /ID# 273507

    RECRUITING

    Troina, Enna, 94018, Italy

  • Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695

    RECRUITING

    Pozzilli, Isernia, 86077, Italy

  • Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463

    RECRUITING

    Bologna, 40139, Italy

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