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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) with the following clinical features: Outpatient, clinically stable and in the residual (non-acute) phase of their illness. No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at week 26
Awards & highlights
Study Summary
This trial is testing whether a medicine called BI 425809 improves learning and memory in people with schizophrenia. People with schizophrenia have difficulty with mental functioning, such as memory and attention. The trial will last 8 months and involve 14 visits to the study site.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the specific side effects of Iclepertin are not listed here, participants will be monitored for any unwanted effects throughout the study. Common drug-related side effects could include nausea, headaches, dizziness or sleep disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on the same antipsychotic medication for at least 12 weeks.
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I have schizophrenia, am stable, and struggle with daily activities.
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I take no more than 1 mg of lorazepam or its equivalent daily.
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I am using or willing to use effective birth control and agree to pregnancy tests.
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I am between 18 and 50 years old.
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I haven't been hospitalized or needed more psychiatric care for my schizophrenia in the last 12 weeks.
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I've been on 1 or 2 antipsychotics (not clozapine) for over 12 weeks and on the same dose for at least 35 days.
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I take 1 mg or less of lorazepam-equivalent daily.
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I meet with my study partner at least once a week in person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at week 26
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) after 26 weeks of treatment
Secondary outcome measures
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test
Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
+1 moreSide effects data
From 2019 Phase 2 trial • 611 Patients • NCT027885135%
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: IclepertinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,286 Total Patients Enrolled
14 Trials studying Schizophrenia
5,016 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been on the same psychoactive medication, except anticholinergics, for at least 12 weeks and on the current dose for over 35 days.I am using or willing to use effective birth control and agree to pregnancy tests.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.I have not undergone electroconvulsive therapy.I am stable and not in the acute phase of my illness.I haven't been hospitalized or needed more psychiatric care for my schizophrenia in the last 12 weeks.I've been on 1 or 2 antipsychotics (not clozapine) for over 12 weeks and on the same dose for at least 35 days.I am on a stable dose of my antipsychotic medication, even if the form has changed.I have been on the same psychoactive medication, except anticholinergics, for at least 12 weeks.I take 1 mg or less of lorazepam-equivalent daily.I haven't had certain treatments in the last 6 months.I am between 18 and 50 years old.I have trouble with daily tasks like talking, focusing, remembering, or navigating.I meet with my study partner at least once a week in person.I am taking two antipsychotics, and both are within the recommended dose limits.I have schizophrenia, am stable, and struggle with daily activities.I am using or willing to use effective birth control and agree to pregnancy tests during the trial.Women who might be able to have children must use contraception that works very well.I've been on 1 or 2 antipsychotics (not clozapine) for at least 12 weeks.I take no more than 1 mg of lorazepam or its equivalent daily.Patients should have difficulty completing day-to-day activities as determined by the investigator.The study partner should be someone who interacts with the patient on a regular basisMy schizophrenia is stable, and I haven't been hospitalized for it in the last 12 weeks.There are more requirements to participate in the study.I am not taking clozapine.I have used ketamine or esketamine.I am currently taking stimulant medications.I am not taking more than the recommended dose of any psychoactive medication.I have a mental health diagnosis other than Schizophrenia.I am between 18 and 50 years old.I have been diagnosed with schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Iclepertin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT04846868 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will this trial be inclusive of patients who are over the age of seventy?
"According to the eligibility requirements listed on the clinical trial, patients must be aged 18-50. There are 47 studies dedicated to those under 18 and 174 for seniors above 65 years old."
Answered by AI
Are there certain restrictions for who can participate in this research study?
"This research is looking for 586 individuals with a diagnosis of schizophrenia that fall between the ages of 18-50. The most crucial inclusion criteria are as follows: Patients must have functional impairment in day-to-day activities per investigator judgement, be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or uncontrolled positive symptoms, maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization, use highly effective methods of birth control if they are women of childbearing potential, have a study partner who interacts with them regularly."
Answered by AI
What is the safety profile of BI 425809?
"BI 425809 is in Phase 3 clinical trials, signifying that while there is data documenting the efficacy of the medication, multiple rounds of testing have verified its safety. Consequently, our team at Power rates BI 425809 as a 3 on our safety scale."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Artemis Institute for Clinical Research, LLC
San Marcus Research Clinic, Inc.
Other
Houston Mind and Brain
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
None of my medications work very well. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
Because i have schizophrenia and would be a part of people helping to find a solution for this terrible illness.
PatientReceived 2+ prior treatments
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