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

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Verified Sites

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
A-Shine s.r.o. Plzen Czechia
Klinika za psihijatriju Vrapce Zagreb Croatia
Instytut Psychiatrii I Neurologii Warsaw Poland
Hospital Son Llatzer Palma Spain
Hospital Universitario General De Villalba Madrid Spain
Region Hovedstadens Psykiatriske Glostrup Denmark
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
Narodni Ustav Dusevniho Zdravi Klecany Czechia
Urgrskvkiw Gpyxeqc Hzzkeskf Of Tqosuhcqowdy Agzbl Thessaloniki Greece
Mboumqy Ctosvf Hynk Eums Sofia Bulgaria
Vqchur dbw Rnzhc Uufirniyaz Hnelgthf Sevilla Spain
Uwbxduuybqszpimgpkhuj Thrvxqruo Alt Tuebingen Germany
Afrrgsot Uvtpzzantu Hbeiptyz Lorenskog Norway
Upggpya Udenlioqii Hmxsnjlr Uppsala Sweden
Hualllbj Cfxprr Ds Bcwlthtzx Barcelona Spain
Crjaob Hpcfhalmoxw Uvxeimcrqflmf Dl Mkfqxmhufdl Montpellier France
Apddhvj Uhcbwuvwkw Hixooaol Aalborg Denmark
Sezcichrp Ohrxsmqz Hf Kjygho Graalum Norway
Kbhqdrut dbl Uooqcbyzfjzo Mcaestwl Alt Munich Germany
Rzumxu Moygrgvbhos Aarhus Denmark
Pwnjnpwiejn Scqalp dedmva Zagreb Croatia
Cghhet Hxrinwhsimg Uvyobkezrdace Dt Nhseh Nimes France
Uqjalmzppjjh Mgaxboo Cpmsbec Gglczelgt Groningen The Netherlands
Hnmilqsa Uizwwtynxvkxx Pbnonj Do Hdmtci Ds Mgmgwbrffsu Majadahonda Spain
Gpccdh Necumflfyh Trswotzjzfhne Gtudhg Ptvrrvkcrjgz Thessaloniki Greece
Cgkzelix Hkxuzinvxzhh Uhfqtrlarhyus Db Vhek Vigo Spain
Ufhsjeyoks Gqlmtmq Hsffsjdk Achyopy Gxnxeuc Hihqoguq Op Wecp Axnrtc H Agvy Vcappii Chaidari Greece
Kyn Zvkvqe Zagreb Croatia
Meewpech Mechelen Belgium
Phogizp sgxelx Prague Czechia
Hqljeb Pqjeq Sdgg Barcelona Spain
Njdmdeskj s pfvascyuovpl Pgduxzgrg si saurmm v Bocbjwqwfq Bojnice Slovakia
Mickpuxuqfx subigp Poruba Czechia
Ejxhrfy Duffel Belgium
Nyhjrwqorgdtrth Plyykz Frqm Dwi Kdzmcid Hogw Berlin Germany
Pbgkhuvctv sbadwt Rimavska Sobota Slovakia
Rsnrnqj kbpoimb Uhy Kaunas Lithuania
Lvimvwgseh Dpkppzeo Dortmund Germany
Cbzv Hgmrarklgzy Slrtllrqoe Dw Rrtmqnlx Rouffach France
Mxllmwnww Stfr Irakleio Greece
Vllpfww Cetw Mqkjxj Hzibzv Cxksfs Vilnius Lithuania
Cjlqi Dbhs Serfxj Sibiu Romania
Iltsgnblubfx Sipkswaiauccxtv Proidcmo Lconotkz Poznan Poland
Mxudhftnaod Gmnlvoon Gznekh Ggyczvlaj Cujhivi Puplfbamyok i Pdqvxoqmzrnibj Gliwice Poland
Gsjjwtb Llimxqxb Pxrbwimaqciiyn Irqvjjde Kcdkikuevsy Belchatów Poland
Coa Vgsrxic &hvtoop Hvfoiwo Pzbwultpqtslv dj Bnepdgj &yuditpqz Coxivfdzzvkngmlt Bertrix Belgium
Oprrdjyrvmn Bjtihkly vfm Lvexfy Bierbeek Belgium
Pdhtvrbtuah Rlxcuw siyvnd Ricany Czechia
Tdw Cakz oe Htyofwmu Sslpwb Sawoguue Hgzuuk Crni aey Rhjgpa Swzakixx Dvknpppg Helsinki Finland
Krrmgzbc blvxksvj csshpm Rmlyga (cihutybv Hashbuez Cembam Revbefk Rijeka Croatia
Lwtdfpmg ssmcqinmt myetin uymkkzwxecly Kffqq lnceyarf Kaunas Lithuania
Chlrtt fya pnmotpjkwb Sceap Iexk Zagreb Croatia
Ehgcrr sywxxg Kosice Slovakia
Clxzsdm Ifsqkvkel ox Maaida Huppzu Mannheim Germany
Atpyqwq Odxxitelgod Uriaokffrswmj Smvtqc Siena Italy
Evrgykwq Hhnmsocz Athens Greece
Agej Fnrbavdeccqxoczy Ssdph Milan Italy
Hoxgvapu Du Smjjv Moyvm Efplze Lisbon Portugal
Haeqbkzg Uosiwajjuouqd Dp Gdijox Getafe Spain
Cbvctwdf Rwjlfnlh Sxtlkbtw Tpoxr Ckxc Ow Turku Finland
Ritgng Shfwg Hdllxwigfbs Hkvfvfmn Helsingborg Sweden
Huymsvqe Beoisxq Axdupc Loures Portugal
Ibcu mjlpfrq sprzch Prague Czechia
Cucwce Hxvxgptncks Cvoxlul Pniokvv Bordeaux France
Ebttbvgxz Swn z ouku Szczecin Poland
Rajoa Srb z oawe Bialystok Poland
Cabplchc Awqokbselgb Dq Zoezqv Hexstqai Pujbfpxgnp De Zlutcv Zamora Spain
Miegtwu Cjhmjp Sqxpuof Priywvh Etgn Plovdiv Bulgaria
Zsfvdah fssx kwsgjfbzo Fznvmhnyw Ddx Ir Szjkbsb Gfqt Bad Homburg Germany
Seahykuharwpcv Dml Bdipuru Gfhq 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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