Study on Long-Term Safety of Iclepertin for Patients with Schizophrenia Who Completed Previous Trials

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What is this study about?

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.

1 entry 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.

2 medication 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.

3 monitoring 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.

4 completion 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Medical Center Hera EOOD Sofia Bulgaria
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
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
Centre Hospitalier Universitaire De Nimes Nimes France
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
KBC Zagreb Zagreb Croatia
A-Shine s.r.o. Plzen Czechia
Nervenärztliche Praxis Frau Dr. Kirsten HahN Berlin Germany
Lietuvos sveikatos mokslu universiteto Kauno ligonine Kaunas Lithuania
Clinic for psychiatry Sveti Ivan Zagreb Croatia
Klinika za psihijatriju Vrapce Zagreb Croatia
Epamed s.r.o. Kosice Slovakia
Central Institute of Mental Health Mannheim Germany
Instytut Psychiatrii I Neurologii Warsaw Poland
Hospital Son Llatzer Palma Spain
Hospital Universitario General De Villalba Madrid Spain
Eginitio Hospital Athens Greece
ASST Fatebenefratelli Sacco Milan Italy
Region Hovedstadens Psykiatriske Glostrup Denmark
Hospital De Santa Maria E.P.E. Lisbon Portugal
Hospital Universitario De Getafe Getafe Spain
Clinical Research Services Turku CRST Oy Turku Finland
Region Skane Helsingborg Hospital Helsingborg Sweden
Hospital Beatriz Angelo Loures Portugal
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
INEP medical s.r.o. Prague Czechia
Centre Hospitalier Charles Perrens Bordeaux France
Euromedis Sp. z o.o. Szczecin Poland
Narodni Ustav Dusevniho Zdravi Klecany Czechia
Revit Sp. z o.o. Bialystok Poland
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
Medical Center Spectar Plovdiv EOOD Plovdiv Bulgaria
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
Aognlefz Uyakzeouuo Hfjnxvim Lorenskog Norway
Ucnabbi Usmrxgpnuh Hyquqcsl Uppsala Sweden
Kcbsjdig der Urmmcyiwkjty Mqvjlqyv Azj Munich Germany
Uruzejgiwxqu Mtslbik Czctvbb Ghqplqxsg Groningen The Netherlands
Cjdzhzjo Hljmqpfpjnma Uibyekoytikiw Dt Vxfj Vigo Spain
Mtllibar Mechelen Belgium
Pobqpae stdlqw Prague Czechia
Hvsccv Petka Sktq Barcelona Spain
Nmwwqqmzp s pfvjdomlavqo Pqjupxuql sv swrdqk v Bpmrlsotoj Bojnice Slovakia
Mhsvmzvxiil scxkrd Poruba Czechia
Ewrlheg Duffel Belgium
Plplwivtxk syfsuw Rimavska Sobota Slovakia
Rkzyiso ksiwsrt Umd Kaunas Lithuania
Lqjwhgpfts Dkqvfeot Dortmund Germany
Clfi Hhpwrimoidv Spkwhwahmk Dj Rmlwjlxk Rouffach France
Meovkujpp Sdlh Irakleio Greece
Vnntafe Cbeh Mgbyzj Hesgeq Covnga Vilnius Lithuania
Cynnb Dfgn Stlddv Sibiu Romania
Irzxsxbrpshl Svvhjzixyhxuula Prcjfvhh Lzgiryma Poznan Poland
Mkvaussnzrw Gtrifmbx Gjihrd Gsgfezeth Ckbgcsh Pkcwlxnjutf i Pctuslobyvubxd Gliwice Poland
Gxmurvk Lmufaocl Pempfxncoxkadw Itjkgcuo Kmknomznrku Belchatów Poland
Cbh Vgqmbnd &oggklq Hdjqqrj Ptndcaxneppqk dy Bilettc &uzzchhkj Clhzgycfygwwirvi Bertrix Belgium
Oiyqelqilqj Burdhyvh vcp Liwuxx Bierbeek Belgium
Pkfzjsyyhip Rovwom sshczi Ricany Czechia
Tcv Cryi oi Hrmhstnc Sfzxhd Sqfrvhif Hbtgxc Coaf ayw Rgozsw Smmizqej Dfzotauv Helsinki Finland
Kgksqrts bcmewjfs cpqmmc Rephin (zbvvojnn Hjujnbca Ccjsxn Rjvqkdu Rijeka Croatia
Afmshdt Occletbisej Uuphbfjclhbhg Szchvo Siena Italy
Syzmhhsdrtckdc Dep Btscnsz Gemz Böblingen Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
03.03.2022
Belgium Belgium
Not recruiting
03.03.2022
Bulgaria Bulgaria
Not recruiting
03.03.2022
Croatia Croatia
Not recruiting
03.03.2022
Czechia Czechia
Not recruiting
03.03.2022
Denmark Denmark
Not recruiting
03.03.2022
Finland Finland
Not recruiting
03.03.2022
France France
Not recruiting
03.03.2022
Germany Germany
Not recruiting
03.03.2022
Greece Greece
Not recruiting
03.03.2022
Hungary Hungary
Not recruiting
03.03.2022
Italy Italy
Not recruiting
03.03.2022
Lithuania Lithuania
Not recruiting
03.03.2022
Norway Norway
Not recruiting
03.03.2022
Poland Poland
Not recruiting
03.03.2022
Portugal Portugal
Not recruiting
03.03.2022
Romania Romania
Not recruiting
03.03.2022
Slovakia Slovakia
Not recruiting
03.03.2022
Spain Spain
Not recruiting
03.03.2022
Sweden Sweden
Not recruiting
03.03.2022
The Netherlands The Netherlands
Not recruiting
03.03.2022

Trial locations

Investigated Drugs:

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.

Investigated Diseases:

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.

Trial ID:
2024-511560-93-00
Protocol code:
1346-0014
Trial Phase:
Therapeutic confirmatory (Phase III)

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