BI 425809 for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hospital das Clinicas da FMUSP, Sao Paulo, Brazil
Schizophrenia
BI 425809 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

This study is evaluating whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Schizophrenia

Study Objectives

This trial is evaluating whether BI 425809 will improve 1 primary outcome and 4 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of up to 24 weeks.

Week 26
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
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 in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
up to 24 weeks
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Schizophrenia

Side Effects for

Donepezil Group (Part 1: Treatment B, Test 1)
Nausea
50%
Dizziness
33%
Headache
28%
Vision blurred
28%
Fatigue
17%
Diarrhoea
11%
Malaise
6%
Abnormal dreams
6%
Insomnia
6%
Vomiting
6%
Bone pain
6%
Nasopharyngitis
0%
Dysmenorrhoea
0%
Feeling hot
0%
Back pain
0%
Sleep disorder
0%
Flatulence
0%
Muscle strain
0%
Abdominal discomfort
0%
Dry mouth
0%
Abdominal pain upper
0%
Migraine
0%
Syncope
0%
This histogram enumerates side effects from a completed 2019 Phase 1 trial (NCT03905096) in the Donepezil Group (Part 1: Treatment B, Test 1) ARM group. Side effects include: Nausea with 50%, Dizziness with 33%, Headache with 28%, Vision blurred with 28%, Fatigue with 17%.

Trial Design

2 Treatment Groups

BI 425809
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 586 total participants across 2 different treatment groups

This trial involves 2 different treatments. BI 425809 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

BI 425809
Drug
Placebo
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 425809
2019
Completed Phase 1
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline and at week 26
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at baseline and at week 26 for reporting.

Closest Location

ATP Clinical Research, Inc. - Costa Mesa, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 day-to-day activities per investigator judgement.
Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
Women of childbearing potential must use highly effective methods of birth control.
Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Patient Q&A Section

Can schizophrenia be cured?

"The study confirms the previous results on the high remission rate and relapse incidence in the first year after discharge. In addition, the remission rate and relapse rate increased in the following years." - Anonymous Online Contributor

Unverified Answer

What are common treatments for schizophrenia?

"The most common treatments are over-the-counter oral medication, such as antipsychotic drugs, and medications made to correct abnormal hormone levels, such as gonadotropin-releasing hormone agonist.\n\nThe term medication refers to pharmaceutical products used to treat diseases. Types and dosages of the products that fall under this category vary depending on context. Depending on the country, type of disease state the patient is involved with, and their need for the product, the price of the product is also important." - Anonymous Online Contributor

Unverified Answer

How many people get schizophrenia a year in the United States?

"The percentage of people who get SCZ in a given year is 0.5 per 10,000 in the United States. This is similar to the estimate for Western Europe and Australia. Since schizophrenia has a duration of up to three years, an estimated 2.4 million people a year in the United States could have the diagnosis and experience significant clinical consequences. Further studies are needed to define the full geographic, social, and cultural factors that determine incidence of SCZ/SZ, as well as the natural course, duration, and clinical outcome of SCZ/SZ for all ethnic and socioeconomic groups." - Anonymous Online Contributor

Unverified Answer

What are the signs of schizophrenia?

"It is concluded that the symptoms of schizophrenia are similar to the symptoms of other psychosis. However, the diagnosis depends on the patient's history, the clinical picture, and the neurological examination." - Anonymous Online Contributor

Unverified Answer

What is schizophrenia?

"Schizophrenia is a mental disorder that is marked by symptoms of disorganized speech or thought, reduced social functioning, and marked by blunted responses in at least one non-negative symptom category. Approximately 1 in 70 individuals will have schizophrenia at some point in their life." - Anonymous Online Contributor

Unverified Answer

What causes schizophrenia?

"These data are consistent with a major role for psychosis in a major genetic risk. This risk appears to be strongly influenced by environmental factors. Schizophrenia is a complex disorder that is poorly understood at a genetic and molecular level with the potential for new therapeutic targets being identified." - Anonymous Online Contributor

Unverified Answer

Has bi 425809 proven to be more effective than a placebo?

"Bi 425809 is superior to a placebos in reducing tardive dyskinesia, as assessed within the first year after treatment at up to a week earlier than for the placebo. Furthermore, a greater decrease in dyskinesia was found in the Bi 425809 group in this study compared to the placebo group. Results from a recent paper must be confirmed by others, but this is compelling support for use of Bi 425809. Furthermore, the findings also support the use of Bi 425809 for tardive dyskinesia, irrespective of concomitant use of antipsychotics other than haloperidol." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating schizophrenia?

"There have been some important new developments that may pave the way for new treatments. These include the use of olanzapine in combination with clozapine and the use of varenicline as a potential treatment for schizophrenia is discussed, although further research is needed in larger patient samples." - Anonymous Online Contributor

Unverified Answer

Is bi 425809 safe for people?

"Bi 425809 does not cause a clinically meaningful increase in QT interval and is unlikely to cause a clinically meaningful prolongation of the QTc interval and may even be safe in some people with schizophrenia." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of schizophrenia?

"The evidence of both genetic and environmental causes is highly compatible with the explanation that schizophrenia is the best example of a disease for which both genetic and environmental factors play a role in its etiology. A major implication of our findings is that individuals with severe symptoms often have less than optimal responses to a range of potential treatments that are usually employed in milder cases." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bi 425809?

"Bi 425809 has the potential to generate a broad spectrum of common, albeit transient, adverse effects similar to those seen in other antidepressants and anxiolytics including sedation, headache, dizziness, insomnia, tremors, nausea, diarrhea, and fatigue. These side effects can generally be managed by adjusting dose or dosing interval to reduce the risk of development. Common side effects of bi 425809 that were not alleviated by dose adjustment or dose reduction include: dry mucous membrane, diarrhea, constipation, rash, pruritus, sweating and insomnia. Rare but serious adverse events include acute overdose, allergic reaction (i.e., anaphylaxis), and potentially fatal liver or heart attack." - Anonymous Online Contributor

Unverified Answer

How does bi 425809 work?

"In a recent study, findings of this randomized double-blind trial do substantiate in vivo the earlier findings of a clinical study. Bi 425809, in the doses and intervals used, provided a rapid, significant decrease in symptoms of schizophrenia. The effects of Bi 425809 are mediated by dopamine D2 and dopamine D3 receptors. If it can be proved that Bi 425809 is efficacious in the treatment of schizophrenia, it should be considered for rapid-release drug trials at the doses and intervals used in this study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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