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
- Diseases
- Parkinson disease
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitatsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Neuro Centrum Science GmbH Coordinator of this site? Confirm its status | Erbach | Germany | Completed |
| University Of Erlangen Nuremberg Coordinator of this site? Confirm its status | Erlangen | Germany | Completed |
| Katholische Kliniken Ruhrhalbinsel gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Curiositas ad sanum Studien- und Beratungs GmbH Innklinikum Haag i.OB Coordinator of this site? Confirm its status | Haag i. OB | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| University Medical Centre Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Universityclinic Giessen And Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Completed |
| University Of Regensburg Coordinator of this site? Confirm its status | Ratisbon | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Policlinica Gipuzkoa Coordinator of this site? Confirm its status | Donostia | Spain | Completed |
| Hospital Ruber Internacional Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Puerta del Sur Coordinator of this site? Confirm its status | Móstoles | Spain | Completed |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| CHRU Lille Hopital Roger Salengro Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Assistance Publique Hopitaux De Marseille Coordinator of this site? Confirm its status | Marseille Cedex 05 | France | Completed |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Completed |
| Carthera Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| CHRU de Strasbourg - Hopital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera S Maria Di Terni Coordinator of this site? Confirm its status | Terni | Italy | Completed |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Krakowskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Michalski I Partnerzy Lekarze sp.p. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Pratia Jelenia Gora Coordinator of this site? Confirm its status | Jelenia Gora | Poland | Completed |
| Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. Coordinator of this site? Confirm its status | Oświęcim | Poland | Completed |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.