This clinical trial is focused on studying the long-term safety of a medication called Iclepertin in individuals with schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. The trial involves participants who have previously completed a 26-week treatment period with Iclepertin or a matching placebo in earlier studies. The medication is taken as a film-coated tablet once daily.
The purpose of this study is to gather additional safety information about Iclepertin in patients who have cognitive impairment due to schizophrenia. Cognitive impairment refers to difficulties with thinking, memory, and concentration, which can be a part of schizophrenia. Participants in this study will continue to take Iclepertin daily for up to 12 months. The study will monitor the occurrence of any new or worsening side effects, known as treatment emergent adverse events, throughout the trial.
In addition to monitoring side effects, the study will also assess changes in the severity of the participants’ condition using a measure called the Clinical Global Impressions – Severity (CGI-S) scale. This scale helps to evaluate how severe the symptoms are at the start of the study compared to the end. The study aims to provide valuable information on the long-term safety of Iclepertin for people living with schizophrenia.
1entry into the extension trial
Participation begins after completing a previous 26-week trial with iclepertin or a placebo. Entry must occur within 2 weeks after the end of the previous trial or within 7 days after the safety follow-up visit, depending on the specific trial completed.
Eligibility requires a diagnosis of schizophrenia, clinical stability, and the presence of a study partner who understands the trial procedures.
2medication administration
The medication, iclepertin, is administered orally in the form of a film-coated tablet. The dosage is once daily.
The purpose of this stage is to monitor the long-term safety of iclepertin in patients with schizophrenia.
3monitoring and assessments
Throughout the trial, the occurrence of any treatment emergent adverse events (TEAEs) is monitored.
Secondary assessments include changes from baseline in Clinical Global Impressions – Severity (CGI-S) and hemoglobin (Hb) levels until the end of treatment.
4completion of the trial
The trial is estimated to conclude by February 24, 2026.
Upon completion, data collected will contribute to understanding the long-term safety of iclepertin in treating cognitive impairment due to schizophrenia.
Who Can Join the Study?
The patient must be an outpatient, meaning they do not need to stay in the hospital overnight, and must be diagnosed with schizophrenia according to a specific guide used by doctors called the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
The patient must have completed 26 weeks of treatment in a previous related trial and must join this new trial within a specific time frame after finishing the previous one.
The patient needs to have a study partner. This is someone who understands the trial procedures, has at least an 8th-grade education, knows the patient well, and can regularly interact with them. It’s best if this is the same person throughout the study.
Additional criteria may apply for participation.
Who Cannot Join the Study?
Patients who did not participate in and complete the 26-week treatment period with Iclepertin or a matching placebo in one of the specified phase III clinical trials.
Patients who do not have cognitive impairment due to schizophrenia.
Patients who are not within the specified age range for the trial.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda
Spain
Hospital De Santa Maria E.P.E.
Lisbon
Portugal
Hospital Universitario De Getafe
Getafe
Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou
Thessaloniki
Greece
Clinical Research Services Turku CRST Oy
Turku
Finland
Region Skane Helsingborg Hospital
Helsingborg
Sweden
Hospital Beatriz Angelo
Loures
Portugal
INEP medical s.r.o.
Prague
Czechia
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Zamora
Spain
Medical Center Spectar Plovdiv EOOD
Plovdiv
Bulgaria
Centre Hospitalier Charles Perrens
Bordeaux
France
Revit Sp. z o.o.
Bialystok
Poland
Euromedis Sp. z o.o.
Szczecin
Poland
Narodni Ustav Dusevniho Zdravi
Klecany
Czechia
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Westerstede
Germany
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Bad Homburg
Germany
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Kaunas
Lithuania
KBC Zagreb
Zagreb
Croatia
A-Shine s.r.o.
Plzen
Czechia
University General Hospital Of Thessaloniki Ahepa
Thessaloniki
Greece
Nervenärztliche Praxis Frau Dr. Kirsten HahN
Berlin
Germany
Virgen del Rocío University Hospital
Sevilla
Spain
Central Institute of Mental Health
Mannheim
Germany
Universitaetsklinikum Tuebingen AöR
Tuebingen
Germany
Hospital Clinic De Barcelona
Barcelona
Spain
Semmelweis University
Budapest
Hungary
Instytut Psychiatrii I Neurologii
Warsaw
Poland
Centre Hospitalier Universitaire De Montpellier
Montpellier
France
Hospital Son Llatzer
Palma
Spain
Aalborg University Hospital
Aalborg
Denmark
Sykehuset Oestfold HF Kalnes
Graalum
Norway
Centre Hospitalier Universitaire De Nantes
Nantes
France
Centre Hospitalier Universitaire De Nice
Nice
France
Region Midtjylland
Aarhus
Denmark
Poliklinika Solmed d.o.o.
Zagreb
Croatia
Hospital Universitario General De Villalba
Madrid
Spain
Eginitio Hospital
Athens
Greece
Hopital Beaujon
Clichy
France
Epamed s.r.o.
Kosice
Slovakia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Chaidari
Greece
Clinic for psychiatry Sveti Ivan
Zagreb
Croatia
Klinika za psihijatriju Vrapce
Zagreb
Croatia
Mtrkzvrm
Mechelen
Belgium
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Groningen
The Netherlands
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Vigo
Spain
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France
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Greece
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Kaunas
Lithuania
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Lithuania
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Romania
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Poland
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Iclepertin is a medication being studied for its potential to help people with schizophrenia who have cognitive impairment. This trial aims to gather more information about the long-term safety of using Iclepertin daily. Participants in this study have already completed a previous trial with Iclepertin, and this extension trial will continue to monitor their health and any side effects they may experience while taking the medication.
Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. Individuals with schizophrenia may experience symptoms such as hallucinations, delusions, and disorganized thinking. These symptoms can lead to difficulties in distinguishing between what is real and what is not. The disorder often begins in late adolescence or early adulthood and can vary in severity. Cognitive impairment is a common feature, affecting memory, attention, and problem-solving skills. The progression of schizophrenia can involve periods of worsening symptoms followed by times of improvement.
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