Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1117568, Placebo.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
Overview
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.
Interventions
- Drug NBI-1117568
Oral capsules - Drug Placebo
Oral capsules
Primary outcome measures
- Time From Randomization to Relapse [Time frame: Up to approximately 30 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Neurocrine Clinical Site — Garden Grove
- Neurocrine Clinical Site — La Habra
- Neurocrine Clinical Site — Lemon Grove
- Neurocrine Clinical Site — Oceanside
- Neurocrine Clinical Site — Torrance
- Neurocrine Clinical Site — West Hills
- Neurocrine Clinical Site — Hollywood
- Neurocrine Clinical Site — Maitland
- … and 12 more centers
Identifiers
NCT: NCT07227818 · NBI-1117568-SCZ3031