Iclepertin for Schizophrenia

Recruiting at 143 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, Ketamine

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: 15

Duration: 26 weeks

620 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a medicine called Iclepertin can help improve memory and learning in adults with schizophrenia. Participants take Iclepertin daily while continuing their usual medication. Doctors regularly check their mental abilities and health throughout the study. Iclepertin is being studied for its potential to improve cognitive functions in schizophrenia.

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.

Eligibility Criteria

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), and experiencing functional impairment in daily activities can join. They must not have been hospitalized for worsening schizophrenia recently, use effective birth control if applicable, and have a study partner who meets regularly.

Inclusion Criteria

I've been on the same antipsychotic medication for at least 12 weeks.

I have been on the same psychoactive medication, except anticholinergics, for at least 12 weeks and on the current dose for at least 35 days.

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

Exclusion Criteria

I have cognitive issues due to a condition like epilepsy, stroke, or head injury.

My side effects from antipsychotic medication can't be managed with low-dose treatments.

History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent.

Timeline

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

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Iclepertin

Trial Overview The trial tests Iclepertin's effect on cognitive functions like learning and memory in people with schizophrenia over 26 weeks. Participants are randomly assigned to receive either Iclepertin or a placebo alongside their standard medication while undergoing regular mental ability assessments.

Participant Groups

Group I: Iclepertin arm Experimental Treatment 1 Intervention

Group II: Placebo arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+