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

RecruitingPhase 3Ages 18 Years - 65 YearsAllNeurocrine Biosciences
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • NBI-1117568
  • Placebo
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Where

25 sites
Neurocrine Clinical Site
Garden Grove, United States
Neurocrine Clinical Site
La Habra, United States
Neurocrine Clinical Site
Lemon Grove, United States
Neurocrine Clinical Site
Oceanside, United States
Neurocrine Clinical Site
Torrance, United States
Neurocrine Clinical Site
West Hills, United States
Neurocrine Clinical Site
Hollywood, United States
Neurocrine Clinical Site
Maitland, United States

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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