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NCT05543252CompletedPhase 2

An extension of the orchestra (PD0053) study to learn how safe minzasolmin is and if it works long-term in participants with Parkinson’s disease

A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSON’S DISEASE

Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Mar 2025

Brief summary (registry, in English)

To estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson’s disease (PD)

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
283 (actual)
First submitted
12 Aug 2022
Start date
28 Dec 2022
Lead sponsor
UCB Biopharma
NCT number
NCT05543252
EU CT number
2022-500424-30-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 283
  • 47 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study - A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding- Study participant had previously participated in PD0055 - Study participant meets any withdrawal criteria in PD0053 - Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study. -Study participant does not agree to refrain from donating blood or blood products or other body fluids.

Who the study is looking for

  • Participant completed the Treatment Period of PD0053. The Baseline Visit for PD0055 (Visit 2) should be no later than 4 weeks following the end of treatment (EOT) Visit in PD0053. Any delay needs to be justified by the Investigator and approved by the Sponsor. - A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of the IMP and refrain from donating sperm during this period- A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of investigational medicinal product (IMP). The study participant must have a negative urine pregnancy test at Screening (Visit 1), which is to be confirmed negative by urine testing prior to the first dose of IMP at PD0055Baseline Visit. If oral contraception is used, an additional barrier method will be required during the study as an IMP-related gastrointestinal upset or a drug interaction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charite Universitatsmedizin Berlin KöR
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BerlinGermanyCompleted
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
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BonnGermanyCompleted
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyCompleted
Neuro Centrum Science GmbH
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ErbachGermanyCompleted
University Of Erlangen Nuremberg
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ErlangenGermanyCompleted
Katholische Kliniken Ruhrhalbinsel gGmbH
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EssenGermanyCompleted
Curiositas ad sanum Studien- und Beratungs GmbH Innklinikum Haag i.OB
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Haag i. OBGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
University Medical Centre Schleswig-Holstein
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KielGermanyCompleted
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
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MainzGermanyCompleted
Universityclinic Giessen And Marburg GmbH
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MarburgGermanyCompleted
University Of Regensburg
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RatisbonGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Policlinica Gipuzkoa
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DonostiaSpainCompleted
Hospital Ruber Internacional
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MadridSpainCompleted
Hospital Universitario HM Puerta del Sur
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MóstolesSpainCompleted
University Clinic of Navarra
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PamplonaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Pellegrin Hospital
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BordeauxFranceCompleted
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceCompleted
CHRU Lille Hopital Roger Salengro
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Lille CedexFranceCompleted
Assistance Publique Hopitaux De Marseille
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Marseille Cedex 05FranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
Carthera
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ParisFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
CHRU de Strasbourg - Hopital de Hautepierre
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StrasbourgFranceCompleted
Hopital Purpan
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Toulouse Cedex 9FranceCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Azienda Ospedaliera di Padova
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PadovaItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Irccs San Raffaele Roma S.r.l.
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RomeItalyCompleted
Azienda Ospedaliera S Maria Di Terni
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TerniItalyCompleted
Stichting Radboud University Medical Center
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NijmegenNetherlandsCompleted
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandCompleted
Krakowskie Centrum Medyczne Sp. z o.o.
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CracowPolandCompleted
Michalski I Partnerzy Lekarze sp.p.
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CracowPolandCompleted
Pratia Jelenia Gora
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Jelenia GoraPolandCompleted
Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala
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KatowicePolandCompleted
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
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LodzPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
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LublinPolandCompleted
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
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OświęcimPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
ETG Neuroscience Sp. z o.o.
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WarsawPolandCompleted
Centrum Medyczne NeuroProtect
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WarsawPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.