NBI-1117568 for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, NBI-1117568, to determine its effectiveness in improving symptoms of schizophrenia, a mental health condition affecting thought and emotion. Participants will receive either the new treatment or a placebo (a pill with no active ingredients) for five weeks to compare effects. The trial seeks adults diagnosed with schizophrenia who are experiencing worsening symptoms severe enough to require hospital care. Participants must be willing to stay in the hospital and adhere to the study rules. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
Yes, if you are taking certain medications like antipsychotics, you must stop them before joining the study.
Is there any evidence suggesting that NBI-1117568 is likely to be safe for humans?
Previous studies found that NBI-1117568 was generally safe and well-tolerated at all tested doses. The number of participants who discontinued the treatment due to side effects was similar to those who stopped when taking a placebo, a pill with no active medicine. This indicates that, overall, participants did not experience more issues with NBI-1117568 than with a dummy pill. These findings suggest the treatment's safety for those considering joining the trial.12345
Why do researchers think this study treatment might be promising for schizophrenia?
Unlike the standard treatments for schizophrenia that primarily focus on dopamine regulation, NBI-1117568 offers a fresh approach by targeting different pathways involved in the condition. Researchers are excited about this treatment because it introduces a novel mechanism of action, potentially offering benefits for patients who do not respond well to existing medications like antipsychotics. Additionally, NBI-1117568 is designed for once-daily oral administration, which could improve adherence and convenience for patients managing their symptoms.
What evidence suggests that NBI-1117568 might be an effective treatment for schizophrenia?
Research has shown that NBI-1117568, which participants in this trial may receive, may help reduce symptoms of schizophrenia. In an earlier study, patients who took 20 mg of this treatment daily experienced noticeable symptom improvement by the third week, as measured by the PANSS score, a tool for evaluating schizophrenia symptoms. The treatment continued to show positive effects by the study's end, suggesting it might offer more benefits than some current treatments. These early findings indicate that NBI-1117568 could effectively manage schizophrenia symptoms.13567
Who Is on the Research Team?
Clinical Development Lead
Principal Investigator
Neurocrine Biosciences
Are You a Good Fit for This Trial?
This trial is for adults with schizophrenia who are currently experiencing a worsening of symptoms that requires hospitalization. Participants must not be taking any prohibited medications, including antipsychotics, and should be willing to stay in the hospital for the study duration and follow all instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either NBI-1117568 or placebo once daily for 5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NBI-1117568
Trial Overview
The trial aims to see if NBI-1117568 can improve behavioral and psychological symptoms of schizophrenia better than a placebo. It's designed to compare the effects of this new treatment against an inactive substance in hospitalized adults.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurocrine Biosciences
Lead Sponsor
Kyle W. Gano
Neurocrine Biosciences
Chief Executive Officer since 2024
PhD in Pharmacology
Dr. Sanjay Keswani
Neurocrine Biosciences
Chief Medical Officer
MD
Citations
1.
neurocrine.gcs-web.com
neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-new-positive-data-phase-2-studyRelease Details - Neurocrine Biosciences
The study showed statistically significant improvements in PANSS total score with 20 mg of NBI-1117568 once daily by Week 3 and at all ...
Neurocrine Biosciences Presents New Positive Data from ...
The primary endpoint was the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 6. The study showed ...
Evaluation of NBI-1117568 in Inpatient Adults With ...
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of ...
4.
psychiatrictimes.com
psychiatrictimes.com/view/positive-phase-2-results-on-nbi-1117568-for-schizophrenia-presented-at-2025-ascp-annual-meetingPositive Phase 2 Results on NBI-1117568 for ...
NBI-1117568 showed significant symptom improvement in schizophrenia, particularly with the 20 mg dose, in a phase 2 study. The study ...
5.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/neurocrine-starts-phase-3-trial-of-nbi-1117568-for-schizophrenia/Neurocrine Starts Phase 3 Trial of NBI-1117568 for ...
The positive Phase 2 results suggest NBI-1117568 could offer improved efficacy and safety compared to existing antipsychotics, potentially ...
Study Details | NCT05545111 | Efficacy, Safety, Tolerability ...
... Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization. Conditions. Schizophrenia.
7.
neurocrine.gcs-web.com
neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-reports-positive-phase-2-data-nbi-1117568Neurocrine Biosciences Reports Positive Phase 2 Data for ...
NBI-'568 was generally safe and well tolerated at all doses studied in the Phase 2 clinical trial. Treatment discontinuation rates due to ...
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