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New gel pump for Parkinson's: Real-World results under scrutiny

NCT ID NCT05043103

Disease control Sponsor: Britannia Pharmaceuticals Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows about 300 adults with advanced Parkinson's who are already using Lecigon, a gel given through a pump to control movement problems. Researchers will track how well it works and what side effects occur over up to two years in everyday medical care. The goal is to see if this treatment helps patients have more 'on' time with fewer mobility swings.

What this could mean

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

Active substance
Levodopa-Entacapone-Carbidopa intestinal gel (Lecigon)
What this could lead to
If successful, this study could confirm that Lecigon helps people with advanced Parkinson's have more good mobility time and fewer daily ups and downs in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Side effects like pump-related issues or drug reactions are possible, and benefits may vary widely among patients.

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

312 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Sep 2026

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

Treating physician's normal patient pool

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 Patients (18 years old and over) with Advanced Parkinson Disease already under treatment with Lecigon® (for up to 3 months before giving informed consent) in accordance with the Summary of Product Characteristics (SmPC) * Patients or legal representative must have signed informed consent to participate in the study * Patients are not taking part in another clinical (interventional) study at the same time Exclusion Criteria: * Patients with contraindications as defined in the current version of the SmPC for Lecigon® * Patients who will not be seen again for their follow up care at the investigator's site after commencement of Lecigon® therapy * Patients with pump placement or pump use issues, e.g. patients with acute severe illness, patients unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse

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Conditions

The condition(s) this trial relates to.

movement disorder Parkinson disease

As listed by the trial registrant

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

Advanced Parkinson disease

Contacts and locations

Locations

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Abteilung für Neurologische Rehabilitation, Gailtal-Klinik

    Hermagor, 9620, Austria

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Bucharest University Emergency Hospital

    Bucharest, 050098, Romania

  • Centre Hospitalier de Wallonie picarde (Chwapi)

    Tournai, 7500, Belgium

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Colentina Hospital Bucharest

    Bucharest, 020125, Romania

  • County Clinical Emergency Hospital of Constanta

    Constanța, 900591, Romania

  • County Emergency Hospital Cluj-Napoca

    Cluj-Napoca, 400347, Romania

  • Department of Neurology, University Medical Centre

    Ljubljana, 1000, Slovenia

  • Emergency County Hospital Targu Mures

    Târgu Mureş, 540136, Romania

  • Emergency Hospital Brasov, Spitalul Clinic Județean de Urgență Brașov

    Brasov, 500326, Romania

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122, Germany

  • Fakultní nemocnice Olomouc

    Olomouc, Czechia

  • Fundeni Clinical Institute

    Bucharest, Romania

  • Ghent University Hospital

    Ghent, Belgium

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de la Princesa

    Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Kepler Universitätsklinikum

    Linz, 4020, Austria

  • Klinik für Neurologie - Universitätsklinikum Essen

    Essen, 45147, Germany

  • Kliniken Beelitz GmbH Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

    Beelitz-Heilstätten, 14547, Germany

  • Klinikum Osnabrück GmbH Klinik für Neurologie

    Osnabrück, 49076, Germany

  • Klinička bolnica Dubrava

    Zagreb, 10000, Croatia

  • Krankenhaus Lindenbrunn

    Coppenbrügge, 31863, Germany

  • Masaryk university

    Brno, Czechia

  • Parkinson-Klinik Ortenau

    Wolfach, 77709, Germany

  • Pécsi Tudományegyetem Klinikai Központ Szemészeti Klinika

    Pécs, 7623, Hungary

  • RKU - Universitäts und Rehabilitationskliniken Ulm gGmbH

    Ulm, 89081, Germany

  • SZTE Szent-Györgyi Albert Klinikai Közpon

    Szeged, 6725, Hungary

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Segeberger Kliniken GmbH Neurologisches Zentrum

    Bad Segeberg, 23795, Germany

  • Semmelweis Egyetem Neurológiai Klinika Budapest

    Budapest, Hungary

  • Skånes universitetssjukhus Lund

    Lund, Sweden

  • Spitalul Universitar de Urgență Elias

    Bucharest, 011461, Romania

  • St. Vincent's University Hospital

    Dublin, D04 T6F4, Ireland

  • Sveti Naum

    Sofia, 1113, Bulgaria

  • The Dublin Neurological Institute, Mater Hospital

    Dublin, D07 R2WY, Ireland

  • Timiş County Emergency Clinical Hospital

    Timișoara, 300723, Romania

  • Timiş County Emergency Clinical Hospital- Neurology 1

    Timișoara, 300723, Romania

  • UHC Osijek, J. Klinici za neurologiju

    Osijek, 31000, Croatia

  • Uniklinik Köln

    Cologne, Germany

  • University Hospital Centre (KBC Zagreb)

    Zagreb, 10000, Croatia

  • University Hospital Centre Rijeka (KBC Rijeka)

    Rijeka, Croatia

  • University Hospital Liege

    Liège, Belgium

  • University Medical Center Groningen

    Groningen, 97139713, Netherlands

  • Universitätsklinik für Neurologie, Medizinische Universität Graz

    Graz, 8036, Austria

  • Universitätsklinik für Neurologie, Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Giessen und Marburg

    Marburg, 35043, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Univerzitetni klinični center Maribor

    Maribor, 2000, Slovenia

  • Uppsala university hospital

    Uppsala, 751 85, Sweden

  • Zentrum für Seltene Erkrankungen Göttingen

    Göttingen, 37075, Germany

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