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Iclepertin for Schizophrenia

Verified Trial
Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signed and dated written informed consent.
Male or female patients who are 18-50 years (inclusive) of age at time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 26
Awards & highlights

Study Summary

This trial is testing whether a medicine called BI 425809 can improve learning and memory in people with schizophrenia. Schizophrenia affects the way a person thinks and their mental functioning. The trial involves taking BI 425809 or a placebo once a day for 26 weeks, in addition to normal medication for schizophrenia.

Who is the study for?
Adults aged 18-50 with schizophrenia, in a stable phase of their illness, can join this study. They need to have been hospitalization-free for the past 12 weeks and not exhibit uncontrolled symptoms. Women must use effective birth control, and all participants should have regular interaction with a study partner.Check my eligibility
What is being tested?
The CONNEX-3 trial is testing if Iclepertin improves learning and memory in people with schizophrenia over placebo. Participants take either Iclepertin or placebo tablets daily for 26 weeks while continuing their usual medication, as mental abilities are assessed through tests.See study design
What are the potential side effects?
While specific side effects of Iclepertin aren't listed here, participants' health will be monitored throughout the study to record any unwanted effects that may arise from taking the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I have been diagnosed with schizophrenia.
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My schizophrenia has been stable with no hospital visits for worsening symptoms in the last 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)
Secondary outcome measures
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London
Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
+1 more

Side effects data

From 2019 Phase 2 trial • 611 Patients • NCT02788513
5%
Headache
5%
Nausea
3%
Dizziness
2%
Nasopharyngitis
2%
Fall
1%
Atrial flutter
1%
Transient ischaemic attack
1%
Pancreatitis acute
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
2 mg BI 425809
5 mg BI 425809
10 mg BI 425809
25 mg BI 425809
Placebo Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Iclepertin treatment groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,321 Total Patients Enrolled
14 Trials studying Schizophrenia
5,016 Patients Enrolled for Schizophrenia

Media Library

Iclepertin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04860830 — Phase 3
Schizophrenia Research Study Groups: Iclepertin treatment group, Placebo group
Schizophrenia Clinical Trial 2023: Iclepertin Highlights & Side Effects. Trial Name: NCT04860830 — Phase 3
Iclepertin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04860830 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being enrolled in the study at this time?

"Yes, the study is still open for recruitment and is looking for 586 total patients from 10 different enrolment sites."

Answered by AI

How many research facilities are currently conducting this investigation?

"In addition to other facilities, this research is being conducted out of Ben Taub General Hospital in Houston, Texas, University of Miami in Miami, California, and Advanced Research Center, Inc. in Anaheim, Georgia."

Answered by AI

Could you explain what possible side effects there are for BI 425809?

"BI 425809's safety is estimated to be a 3. This is due to it being a Phase 3 trial, which suggests that not only is there data supporting its efficacy, but also that multiple rounds of testing have yielded positive results in terms of safety."

Answered by AI

Does this research involve people who are over 25 years old?

"This trial is for patients aged 18-50. There are 47 trials for patients younger than 18 and 172 for patients older than 65."

Answered by AI

How many medical participants are involved in this clinical trial?

"In order to move forward with this study, 586 eligible patients must be recruited from various locations including Ben Taub General Hospital in Houston, Texas and University of Miami in Miami, California."

Answered by AI

What are the requirements to qualify for participation in this clinical trial?

"This study is recruiting 586 patients with schizophrenia aged 18 and 50. Most notable, applicants must meet the following criteria: Signed and dated written informed consent., Male or female patients who are 18-50 years (inclusive) of age at time of consent., Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)., -- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms., Patients should have functional impairment in"

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Nova Psychiatry Inc.
Advanced Medical Research Group Inc
Other
Ben Taub General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2

How responsive is this trial?

Most responsive sites:
  1. Arch Clinical Trials: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
2021. "CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04860830.
All > Schizophrenia
~112 spots leftby Jan 2025
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