NBI-1117568 for Schizophrenia

Recruiting at 4 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neurocrine Biosciences

Must not be taking: Antipsychotics

Disqualifiers: Substance use disorder, Unstable condition, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

284 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

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

Key

I have been diagnosed with schizophrenia.

I am currently hospitalized due to a sudden worsening of my symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NBI-1117568 or placebo once daily for 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: NBI-1117568 Experimental Treatment 1 Intervention

Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD