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Study on the Long-Term Safety and Effectiveness of Minzasolmin and Iodine Ioflupane (123I) in Patients with Parkinson’s Disease

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What is this study about?

This clinical trial is focused on studying Parkinson’s disease, a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination. The study is evaluating a treatment called minzasolmin, also known by its code name UCB0599. This treatment is being tested to see how safe it is and whether it works effectively over a long period for people with Parkinson’s disease. Another substance used in the study is iodine ioflupane (123I), which is a chemical used in imaging to help understand changes in the brain.

The purpose of the study is to assess the effects of minzasolmin on the brain in participants who have been newly diagnosed with Parkinson’s disease. Participants in the study will receive either minzasolmin or a placebo, which looks like the treatment but does not contain the active substance. The study will follow participants over time to monitor the safety and effectiveness of the treatment. Participants will undergo various assessments, including imaging tests, to track changes in their condition.

This study is an extension of a previous study, and it aims to provide more information about the long-term use of minzasolmin in treating Parkinson’s disease. The study will help researchers understand how the treatment affects the brain and whether it can improve symptoms or slow the progression of the disease. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

1 screening and baseline visit

Upon joining the study, the first step is the screening and baseline visit. During this visit, a urine pregnancy test is conducted to confirm a negative result before the first dose of the investigational medicinal product (IMP).

Participants must have completed the treatment period of the previous study, PD0053, and the baseline visit for this study should occur no later than four weeks after the end of treatment visit in PD0053.

2 treatment period

During the treatment period, participants will receive the investigational medicinal product, minzasolmin (UCB0599), in the form of a capsule for oral use. The dosage and frequency will be determined by the study protocol.

Participants are required to use contraception during the treatment period and for at least 90 days after the last dose of the IMP. Women of childbearing potential must follow contraceptive guidance during the treatment period and for at least one month after the last dose.

3 follow-up visits

Throughout the study, participants will attend regular follow-up visits to monitor their health and the effects of the treatment. These visits will include assessments such as imaging tests to evaluate brain function and other health checks.

Participants will be monitored for any adverse events or side effects, and the study team will adjust the treatment as necessary to ensure safety and tolerability.

4 end of study

At the end of the study, participants will undergo a final assessment to evaluate the long-term efficacy, safety, and tolerability of the treatment.

The study is estimated to conclude by April 2027, and participants will be informed of the results and any further steps if needed.

Who Can Join the Study?

  • The participant must have completed the Treatment Period of a previous study called PD0053. The next visit for this study should be no later than 4 weeks after the end of the previous study, unless there is a justified reason approved by the study team.
  • A male participant must agree to use contraception during the study and for at least 90 days after the last dose of the study medication. He must also agree not to donate sperm during this time.
  • A female participant can join if she is not pregnant, not breastfeeding, and meets one of the following conditions:
    • She is not able to become pregnant.
    • If she can become pregnant, she agrees to use contraception during the study and for at least 1 month after the last dose of the study medication. She must have a negative pregnancy test before starting the study.
  • If a female participant uses oral contraception, she must also use an additional barrier method (like a condom) during the study because the study medication might affect how well the oral contraception works.
  • The participant must be able to give signed informed consent, which means they understand the study and agree to follow the rules and restrictions.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of Parkinson’s disease cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have any other medical condition that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are taking certain medications that might interfere with the study cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have a known allergy to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Lodz Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala Katowice Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Centre Hospitalier Universitaire De Lille Lille France
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Hospital Universitario De Navarra Pamplona Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Etg Neuroscience Sp. z o.o. Warsaw Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Centre Hospitalier Universitaire De Toulouse Toulouse France
Irccs San Raffaele Roma S.r.l. Rome Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Azienda Ospedaliera S Maria Di Terni Terni Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Ruber Internacional Madrid Spain
Pellegrin Hospital Bordeaux France
Universita Degli Studi Di Brescia Brescia Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Neuroprotect Sp. z o.o. Warsaw Poland
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Katholische Kliniken Ruhrhalbinsel gGmbH Essen Germany
Neuro Centrum Science GmbH Erbach Germany
Carthera Paris France
Pratia Jelenia Gora Jelenia Gora Poland
Curiositas ad sanum Studien- und Beratungs GmbH Innklinikum Haag i.OB Haag i. OB Germany
Uchjxgmstzbqjeltwetyc Gagbrjw uyy Mqmuwsx Gyws Marburg Germany
Smbfumlvb Ruafqyl Urrgdqmztt Mpourgy Clrgqw Nijmegen The Netherlands
Mujkavuxt i Pqtrtabiq Lutrtpn Swvyyz Pgtawgkxjoh Cracow Poland
Arxxerjxiv Ptpgounk Hiufmhsi Dm Mqjabuzbf Marseille France
Hgutbhdi Do Ld Swfyf Ctxh I Snwa Prb Barcelona Spain
Hzxbnrt Hglba Mhfmzy &kkvdel 1 rvo Goypvkw Eypyig Creteil France
Izoipwpo Zsvgkuu Du Bgfgmzcnxizdxhhzz Oświęcim Poland
Hcwsmdgz Uyxxeqmkdnwho dd A Csgslt A Coruna Galicia Spain
Hsrpdbbl Uuittvhvbqcrlb Sybqoaxqhr &ckgqcb Hccazei dv Hqauanzsuea STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
21.11.2022
Germany Germany
Not recruiting
21.11.2022
Italy Italy
Not recruiting
21.11.2022
Poland Poland
Not recruiting
21.11.2022
Spain Spain
Not recruiting
21.11.2022
The Netherlands The Netherlands
Not recruiting
21.11.2022

Trial locations

Investigated drugs:

UCB0599 is a medication being studied for its potential to help people with Parkinson’s disease. Parkinson’s disease is a condition that affects the brain and can cause problems with movement, balance, and coordination. This medication is being tested to see if it can slow down or change the way the disease affects the brain over time. The study is looking at how the medication works in people who start taking it early in their diagnosis compared to those who start taking it later. The goal is to understand if starting the medication earlier can have better effects on the brain and help manage the symptoms of Parkinson’s disease more effectively.

Investigated diseases:

Parkinson’s disease – Parkinson’s disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with barely noticeable tremors in one hand. As it advances, individuals may experience slower movement, muscle rigidity, and impaired posture. Over time, the symptoms can become more severe, affecting daily activities and leading to difficulties in walking and talking. The progression of Parkinson’s disease varies among individuals, with some experiencing rapid changes and others having a slower progression.

Trial ID:
2022-500424-30-00
Protocol code:
PD0055
NCT ID:
NCT05543252
Trial Phase:
Therapeutic exploratory (Phase II)

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