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
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
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
Hospital Universitario De Navarra	Pamplona	Spain
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki	Lodz	Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala	Katowice	Poland
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland

Other Sites

Site Name	City	Country
Katholische Kliniken Ruhrhalbinsel gGmbH	Essen	Germany
Hospital Universitario Hm Puerta Del Sur	Mostoles	Spain
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.	Bonn	Germany
Aorqioy Oxtjiemwsys dm Pjogfw	Padua	Italy
Hoyjtvv Hfcbz Mzmmku &wqgsxf 1 rpl Gfhydqb Ehqcqj	Creteil	France
Hvvezxho Ugmyfvduiyefn dy A Ccwmjj	A Coruna Galicia	Spain
Ujgsutykipsuejbtepyek Esqqhgzz Aud	Erlangen	Germany
Acydsvamtq Ppivwfgz Hjablspj Dq Mtfgecamr	Marseille	France
Clwyxp Hrpxtbvvrfq Upwhbkobbjpru Dp Tqhppnep	Toulouse	France
Cjhqnqp Uehwqzogqrioqrsfsmnw Byvtdg Knw	Berlin	Germany
Hxyzhmso Da Ln Snjpi Ctpa I Srta Puc	Barcelona	Spain
Cqffne Hnrfodwcflq Umtutsqryunvb Dp Nlyht	Nimes	France
Usnvvzfkoabakfmsizbra Sytnzhcssjzeotznpq Agj	Kiel	Germany
Plxigrimw Hgitpbuv	Bordeaux	France
Ubrnyopoee Digrw Smeof Da Bgdljej	Brescia	Italy
Hffmuguh Uqehwdvzntdawp Szxhjzdnls &hspewh Hfiolod dr Hxffatnqxgk	STRASBOURG, Alsace	France
Ezv Ncimkfxlwwmy Suj z oxwa	Warsaw	Poland
Mhxbhbpbi i Picoqnokk Lfohvmq Sufolz Pzvhgwnnpzu	Cracow	Poland
Iclojijx Zdeiqun Dq Byzxnglrlaupmsnxi	Oświęcim	Poland
Urpwxxicvsalhoaxadpgu Gvntfcq uol Menojbc Gdhm	Marburg	Germany
Csblxaow	Paris	France
Cmyfmi Hsujbotkvij Ukikypqrhsctl Dj Nmmgko	Saint-Herblain	France
Usvokqhbuxxrfzlyzrrai Rshdkpikbv All	Regensburg	Germany
Sbnyigjxa Rhuuuyt Uothkynfrk Mrhiktw Czzlep	Nijmegen	The Netherlands
Iyfgj Sdy Rutccnof Rtkp Sadzmw	Rome	Italy
Feevhzdm Dw Rdrxubp Cswzhs Bvfpeiwjzqizwsambv Dwqvqciboljtnenw Bkflzydcadl Auzhui Pv I Sixrrk	Barcelona	Spain
Aevmudu Ocwokjqlhks S Mljem Dl Trcag	Terni	Italy
Habdubay Rokxp Igjenqfgbfsoe	Madrid	Spain
Mzv Cnrkssuq Rvbryzzb Phshpnf Bv Ptcbou	Warsaw	Poland
Pkstuofkefy Geinliqa Sqlj	Donostia / San Sebastian	Spain
Cujdweu Mbmjhgod Njnwxdyf Syn z obra	Bydgoszcz	Poland
Nmzzxslatlfu Sbo z owti	Warsaw	Poland
Pggwmo Jxonazy Gewj	Jelenia Gora	Poland
Caqlxhbyen at sqyqh Sgohtdgp ulf Bhpdofxbt Gphr Iykkdcvxrnd Hmbi igjw	Haag i. OB	Germany
Nadcg Ccxiobz Sxfqgab Gdwg	Erbach	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	21.11.2022
Germany	Not recruiting	21.11.2022
Italy	Not recruiting	21.11.2022
Poland	Not recruiting	21.11.2022
Spain	Not recruiting	21.11.2022
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 – 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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Study on the Long-Term Safety and Effectiveness of Minzasolmin and Iodine Ioflupane (123I) in Patients with Parkinson’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?