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New hope for Parkinson's: drug pump studied for earlier use

NCT ID NCT06916507

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study looks at how well the drug combination Foslevodopa/Foscarbidopa works for people with early advanced Parkinson's disease in everyday German clinics. About 125 adults aged 18-64 who are already prescribed this drug will be followed for up to 12 months. Researchers will track changes in 'OFF' time (when symptoms return between doses), quality of life, and work ability.

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 show that starting this treatment earlier in advanced Parkinson's helps control motor symptoms and improves daily life and work ability.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is small (125 people) and only follows patients for 12 months, so long-term benefits or risks remain unclear.

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 125 people

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

Started

May 2025

Expected to finish

Sep 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's disease with time since the beginning of motor fluctuations ≤3 years and the Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany

Ages

18 to 64 years

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 idiopathic Parkinson's disease * Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label * Participant must be an adult male or female, 18-64 years of age * Time since beginning of motor fluctuations ≤ 3 years * The Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition * Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study Exclusion Criteria: * Previous Exposure to any device-aided therapy (DAT). * Any condition included in the contraindications section of the approved local LDp/CDp label. * Participants with Mini mental state examination (MMSE) score \< 24

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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's 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

  • Asklepios Fachklinikum Stadtroda /ID# 274162

    RECRUITING

    Stadtroda, Thuringia, 07646, Germany

  • Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865

    RECRUITING

    Cologne, North Rhine-Westphalia, 50668, Germany

  • Kliniken Schmieder - Allensbach /ID# 285402

    RECRUITING

    Allensbach, Baden-Wurttemberg, 78476, Germany

  • Klinikum Bremen-Nord /ID# 275822

    RECRUITING

    Bremen, 28755, Germany

  • Klinikum Dortmund Klinikzentrum Mitte /ID# 280222

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Klinikum Ernst von Bergmann /ID# 274176

    RECRUITING

    Potsdam, Brandenburg, 14467, Germany

  • Klinikum Ingolstadt /ID# 280573

    RECRUITING

    Ingolstadt, Bavaria, 85049, Germany

  • Klinikum Lippe Detmold /ID# 279451

    RECRUITING

    Detmold, North Rhine-Westphalia, 32756, Germany

  • Klinikum der Universitaet Muenchen Grosshadern /ID# 274168

    RECRUITING

    Munich, Bavaria, 81337, Germany

  • Knappschaftskrankenhaus Bottrop /ID# 274284

    RECRUITING

    Bottrop, North Rhine-Westphalia, 46242, Germany

  • Krankenhaus Martha-Maria Halle-Dolau /ID# 274174

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161

    RECRUITING

    Wolfach, Baden-Wurttemberg, 77709, Germany

  • Praxis MD Oehlwein /ID# 274222

    RECRUITING

    Gera, Thuringia, 07551, Germany

  • Praxis Prof. Kassubek/Prof. Riecker /ID# 274165

    RECRUITING

    Ulm, Baden-Wurttemberg, 89073, Germany

  • Universitaetskliniken Giessen und Marburg /ID# 274224

    RECRUITING

    Marburg, Hesse, 35043, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen /ID# 280831

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Heidelberg /ID# 274164

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Tuebingen /ID# 275828

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

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