NBI-1117568 to prevent relapse in adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study gives adults with schizophrenia an open-label course of NBI-1117568 and then compares continued NBI-1117568 with placebo to measure time to relapse. Adults who show a stable response during the open-label period are randomized into a placebo-controlled continuation phase to see if ongoing treatment delays symptom return. Key inclusion criteria include a DSM-5-TR diagnosis of schizophrenia for at least one year and prior positive response to at least one antipsychotic (excluding clozapine), while participants with unstable medical conditions or significant laboratory abnormalities are excluded. The trial is conducted at Neurocrine Clinical Sites in Southern California and tracks relapse rates and safety during the randomized phase.

Why it matters

Who can join: the full rules

Key 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.

Key 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.

Where it's running

• Neurocrine Clinical Site
  Garden Grove, California, United States Recruiting
• Neurocrine Clinical Site
  La Habra, California, United States Recruiting
• Neurocrine Clinical Site
  Lemon Grove, California, United States Recruiting
• Neurocrine Clinical Site
  Oceanside, California, United States Recruiting
• Neurocrine Clinical Site
  Torrance, California, United States Recruiting
• Neurocrine Clinical Site
  Hollywood, Florida, United States Recruiting

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.