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BI 425809 for Schizophrenia

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening (28 days prior to first drug drug administration), at baseline and at weeks 6 and 12 after first drug administration.
Awards & highlights

Study Summary

This trial is testing whether a medication, BI 425809, can improve mental abilities when taken with brain training. The study will last for 12 weeks, during which participants will take the medication once a day. Doctors will monitor the participants' mental abilities and health throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening (28 days prior to first drug drug administration), at baseline and at weeks 6 and 12 after first drug administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening (28 days prior to first drug drug administration), at baseline and at weeks 6 and 12 after first drug administration. 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 Neurocognitive Function as Measured by the Neurocognitive Composite Score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment
Secondary outcome measures
Change From Baseline in Cognitive Function as Measured by the Overall MCCB Composite T Score (Including Social Cognition) After 12 Weeks of Treatment
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After 12 Weeks of Treatment
Change From Baseline in the Effect of Cognitive Deficit on Day-to-day Functioning as Measured by SCoRS Total Score After 12 Weeks of Treatment
+1 more

Side effects data

From 2022 Phase 2 trial • 200 Patients • NCT03859973
7%
Headache
3%
Vomiting
1%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Computerized Cognitive Training
BI 425809 10 mg + Computerized Cognitive Training

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 425809 10 mg + Computerized Cognitive TrainingExperimental Treatment1 Intervention
Group II: Placebo + Computerized Cognitive TrainingPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 425809
2019
Completed Phase 2
~630

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,374 Total Patients Enrolled
14 Trials studying Schizophrenia
5,402 Patients Enrolled for Schizophrenia

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
Asclepes Research Centers
IUSMM Institut Universitaire en Sante Mentale de Montreal
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Asclepes Research Centers: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
Clinical Drug InvestigationJournal
Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial
Harvey, Philip D., Christopher R. Bowie, Sean McDonald, and Jana Podhorna. 2020. “Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial”. Clinical Drug Investigation. Springer Science and Business Media LLC. doi:10.1007/s40261-020-00893-8.
clinicaltrials.govStudy
This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
2019. "This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03859973.
~33 spots leftby Apr 2025
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