Iclepertin for Schizophrenia

Recruiting at 157 trial locations

Overseen By Boehringer Ingelheim

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Antipsychotics

Must not be taking: Clozapine, Stimulants

Disqualifiers: Bipolar, Major depressive, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 26 weeks

611 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a daily pill called Iclepertin can improve learning and memory in adults with schizophrenia. Participants take either Iclepertin or another pill for several months while continuing their usual medication. Doctors regularly check their mental abilities and overall health.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants are required to continue their normal medication for schizophrenia during the trial.

How does the drug Iclepertin differ from other schizophrenia treatments?

Iclepertin is not directly mentioned in the provided research, but similar drugs like lumateperone are unique because they modulate serotonin, dopamine, and glutamate neurotransmission, which are key chemicals in the brain involved in schizophrenia. This approach aims to treat a wide range of symptoms with fewer side effects compared to traditional antipsychotics. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), not hospitalized for worsening symptoms in the last 12 weeks. Must have a study partner and be capable of consent. Women must use effective birth control.

Inclusion Criteria

I am taking two antipsychotics, and both are within the recommended dose limits.

I am on a stable dose of my antipsychotic medication, even if the form has changed.

I am not taking more than the allowed dose of any psychoactive medication.

Exclusion Criteria

I haven't used specific medications like Clozapine or undergone treatments like ECT in the last 6 months.

I am between 18 and 50 years old.

Have you been hospitalized for worsening schizophrenia symptoms in the past year?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take Iclepertin or placebo tablets once daily for 26 weeks, with regular assessments of learning and memory

26 weeks

15 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iclepertin

Trial Overview The trial tests if Iclepertin improves cognition compared to placebo over 26 weeks. Participants also continue their usual schizophrenia medication, attend regular visits for health checks and cognitive assessments using questionnaires and computer tests.

How Is the Trial Designed?

Group I: Iclepertin Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Lumateperone (CAPLYTA™) is a novel antipsychotic approved for treating schizophrenia, showing efficacy in managing a broad range of symptoms, including positive symptoms and comorbid depression, based on data from 20 clinical trials involving over 1900 participants.

This medication works by simultaneously modulating serotonin, dopamine, and glutamate neurotransmission, which contributes to its effectiveness while maintaining a favorable safety profile with fewer intolerable side effects compared to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the pharmacology and clinical profile of lumateperone for the treatment of schizophrenia. Snyder, GL., Vanover, KE., Davis, RE., et al.[2021]

In a phase 3 clinical trial involving 450 patients, lumateperone (42 mg) significantly improved schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores.

Lumateperone was well tolerated, showing no significant motor side effects or adverse changes in cardiometabolic or endocrine factors, suggesting it may be a safer alternative to current antipsychotic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. Correll, CU., Davis, RE., Weingart, M., et al.[2021]

Iloperidone has been shown to be effective in treating schizophrenia, with multiple dosing groups demonstrating significant improvements over placebo in three randomized, double-blind studies involving 1943 patients.

Iloperidone was associated with a lower risk of motor-related side effects compared to other antipsychotics like risperidone and haloperidol, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. Potkin, SG., Litman, RE., Torres, R., et al.[2022]

Lumateperone (Caplyta®) is a first-in-class medication that modulates serotonin, dopamine, and glutamate, making it a unique treatment option for schizophrenia and potentially other neuropsychiatric disorders.

Approved in December 2019 for schizophrenia in adults, lumateperone is also being studied for various conditions, including bipolar depression and Alzheimer's-related behavioral disorders, highlighting its broad therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. Blair, HA.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A review of the pharmacology and clinical profile of lumateperone for the treatment of schizophrenia. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Iloperidone: in schizophrenia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. [2021]