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

Purpose

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.

Condition

  • Schizophrenia

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. - Participant had the initial diagnosis of schizophrenia ≥1 year before screening. - Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.

Exclusion Criteria

  • Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological [including dementing illness, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1. - Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease. - Participant has a history of clozapine treatment for treatment-resistant psychosis. - Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening. - Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The initial Open-label Stabilization Period is open-label and non-randomized.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NBI-1117568 		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.
  • Drug: NBI-1117568
    Oral capsules
Placebo Comparator
Placebo 		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.
  • Drug: NBI-1117568
    Oral capsules
  • Drug: Placebo
    Oral capsules

Recruiting Locations

Neurocrine Clinical Site
Garden Grove, California 92845

Neurocrine Clinical Site
La Habra, California 90631

Neurocrine Clinical Site
Lemon Grove, California 91945

Neurocrine Clinical Site
Oceanside, California 92056

Neurocrine Clinical Site
West Hills, California 91307

Neurocrine Clinical Site
Hollywood, Florida 33024

Neurocrine Clinical Site
Maitland, Florida 32751

Neurocrine Clinical Site
Miami, Florida 33122

Neurocrine Clinical Site
Tampa, Florida 33629

Neurocrine Clinical Site
West Palm Beach, Florida 33024

Neurocrine Clinical Site
Atlanta, Georgia 30318

Neurocrine Clinical Site
Boston, Massachusetts 02116

Neurocrine Clinical Site
Flowood, Mississippi 39232

Neurocrine Clinical Site
Cedarhurst, New York 11516

Neurocrine Clinical Site
New York, New York 10029

Neurocrine Clinical Site
New York, New York 10036

Neurocrine Clinical Site
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

Neurocrine Medical Information Call Center
1-877-641-3461
medinfo@neurocrine.com