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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Iclepertin – Iclepertin is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials for its long-term safety in patients with schizophrenia, particularly those with cognitive impairment. The main therapeutic indication for Iclepertin is schizophrenia, focusing on improving cognitive function. At the molecular level, Iclepertin works by modulating neurotransmitter systems in the brain, which are believed to be involved in cognitive processes. It is classified pharmacologically as a cognitive enhancer.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511560-93-00Protocol code1346-0014Estimated enrolment1 509 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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