Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neurocrine Biosciences

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

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

Inclusion Criteria

Have you been diagnosed with schizophrenia by a healthcare provider?

Were you first diagnosed with schizophrenia at least 1 year ago?

Have you previously had a positive response to at least one antipsychotic medication (other than clozapine)?

Exclusion Criteria

Have you had moderate or severe issues with alcohol or drug use in the past 6 months?

Have you had recent thoughts of harming yourself or others, or been considered at risk for suicide?

Have you ever been treated with clozapine for treatment-resistant schizophrenia?

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: NBI-1117568 Experimental Treatment 1 Intervention

All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.

Group II: Placebo Placebo Group 2 Interventions

All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.

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