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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at week 26
Awards & highlights
Study Summary
This trial is testing whether BI 425809 improves learning and memory in people with schizophrenia. Participants will take the medication for 8 months and have their progress monitored by doctors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified in the provided information but generally could include typical drug-related reactions such as nausea, headaches, dizziness or other unexpected issues that will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
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I have been diagnosed with schizophrenia according to DSM-5.
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I am between 18 and 50 years old.
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My schizophrenia symptoms are moderate based on specific PANSS scores.
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I've been on 1 or 2 antipsychotic drugs, except clozapine, for over 12 weeks.
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I take no more than 1 mg of lorazepam or its equivalent daily.
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
Schizophrenia
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
11,340,321 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 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.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.My study partner meets with me at least once a week, including in-person.You have had thoughts of harming yourself in the past three months, but if a licensed mental health professional confirms that you are not at immediate risk of harming yourself, you can still participate in the study.I am currently on medication for my condition.I am between 18 and 50 years old.I am currently on medication for my condition.I have a study partner who can attend appointments with me.I have a study partner who can attend appointments with me.My schizophrenia is stable, and I haven't been hospitalized for it in the last 12 weeks.I've been on the same antipsychotic medication for at least 12 weeks.I have a study partner who can attend appointments with me.I have severe movement issues not controlled by low-dose medication.You have had serious thoughts about hurting yourself in the past 3 months, and have made a plan to do so.I take no more than 1 mg of lorazepam or its equivalent daily.I am between 18 and 50 years old.I am currently on medication for my condition.I am between 18 and 50 years old.You have functional impairment in day-to-day activities.My schizophrenia symptoms are moderate based on specific PANSS scores.I have been diagnosed with schizophrenia according to DSM-5.You have shown signs of attempting to harm yourself in the past year leading up to screening or during the screening period.I have a study partner who can attend appointments with me.I am between 18 and 50 years old.I am currently on medication for my condition.I am currently on medication for my condition.I have a study partner who can attend appointments with me.I am between 18 and 50 years old.I am currently on medication for my condition.I have a study partner who can attend appointments with me.I am currently on medication for my condition.I have a study partner who can attend appointments with me.I am between 18 and 50 years old.I am between 18 and 50 years old.I have been diagnosed with schizophrenia and am currently in a stable phase.I've been on 1 or 2 antipsychotic drugs, except clozapine, for over 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 between 18 and 50 years old.I have cognitive issues due to a condition like stroke, head injury, dementia, or epilepsy.There are additional requirements that need to be met for you to be included in the study.You have trouble with everyday tasks like having conversations, staying focused, remembering instructions or getting to places, as determined by the study team.You had a serious problem with drugs or alcohol within the last 12 months. This doesn't include caffeine or nicotine addiction.
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: NCT04846881 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If an elderly person is interested in this study, will they be able to participate?
"Individuals that fall between 18-50 years old are welcome to apply for this study."
Answered by AI
Could you please explain the potential side effects of BI 425809?
"BI 425809 has received a score of 3 for safety. This is due to it being a Phase 3 trial, where there is some data backing up the efficacy of the medication as well as multiple rounds of supportive safety data."
Answered by AI
Could I potentially be a candidate for this research study?
"This international medical trial is looking for 586 patients that have been diagnosed with schizophrenia by the DSM-5. To meet eligibility requirements, participants must be between 18-50 years old, have functional impairment in day-to-day activities, and not be taking any other psychoactive medications (with the exception of anticholinergics). Patients must also have a study partner who can regular check-ins."
Answered by AI
Are there any vacancies in this clinical trial for new test subjects?
"Yes, the data on clinicaltrials.gov indicates that this study is actively seeking participants. The trial was initially posted on 6/7/2021 and was last edited on 11/14/2022. The study is looking for 586 patients between 15 sites."
Answered by AI
How many people are allowed to join this clinical trial?
"In order to perform this clinical trial, 586 willing and eligible patients are required. These participants can come from different sites, such as Innovative Clinical Research in Lauderhill, Florida or Relaro Medical Trials, LLC in Dallas, Texas."
Answered by AI
In how many different medical facilities is this research being conducted today?
"At the moment, eligible patients can enroll at one of four clinical trial sites which are located in Lauderhill, Florida; Dallas, Texas; New Haven, Connecticut or any of the other 15 active locations."
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Texas
How old are they?
18 - 65
What site did they apply to?
ASCLEPES Research Centers, P.C. dba Alliance Research
Research in Miami Inc
Other
Relaro Medical Trials
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
2
0
Why did patients apply to this trial?
No Take any drugs. I’m hoping the trial will go good. Because I battle with schizophrenia on a day to day status.
PatientReceived no prior treatments
I am trying to see what can help me to improve my daily actives. I was hoping to help with clinical studies while earning some money.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How much do it pay? Do I have to sleep there? Can the screenings be done virtually?
PatientReceived no prior treatments
How much is the compensation for the trial? How long do the screening visits take? How long is the trial?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- ASCLEPES Research Centers, P.C. dba Alliance Research: < 24 hours
- Relaro Medical Trials: < 48 hours
Average response time
- < 2 Days
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