NBI-1117568 for adults hospitalized with schizophrenia
A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
PHASE3 · Neurocrine Biosciences · NCT07105098
This trial will test whether NBI-1117568 helps improve behavioral and psychological symptoms in adults hospitalized for worsening schizophrenia compared with a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neurocrine Biosciences (industry) |
| Locations | 11 sites (Culver City, California and 10 other locations) |
| Trial ID | NCT07105098 on ClinicalTrials.gov |
What this trial studies
This Phase 3, placebo-controlled inpatient trial compares NBI-1117568 with placebo in adults who are experiencing an acute exacerbation of schizophrenia and require hospitalization. Participants must discontinue prohibited antipsychotics before enrollment and remain in a supervised inpatient setting while receiving study medication or placebo. The primary outcome is change in behavioral and psychological symptoms of schizophrenia from baseline compared with placebo, with safety and tolerability monitored throughout the inpatient period.
Who should consider this trial
Good fit: Adults with a primary diagnosis of schizophrenia who are experiencing an acute relapse that warrants inpatient care, are willing to discontinue prohibited antipsychotics, and can remain hospitalized for the study duration are the ideal candidates.
Not a fit: Patients with unstable or poorly controlled medical conditions, recent moderate-to-severe substance use disorder, imminent suicide or violence risk, or known hypersensitivity to the drug are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, NBI-1117568 could reduce acute behavioral and psychological symptoms and potentially shorten or ease hospital stays for adults with schizophrenia.
How similar studies have performed: Placebo-controlled trials of other antipsychotics have demonstrated symptom improvements in acute schizophrenia, but NBI-1117568's efficacy is still being tested in this Phase 3 program.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568 * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Where this trial is running
Culver City, California and 10 other locations
- Neurocrine Clinical Site — Culver City, California, United States (RECRUITING)
- Neurocrine Clinical Site — Garden Grove, California, United States (RECRUITING)
- Neurocrine Clinical Site — Riverside, California, United States (RECRUITING)
- Neurocrine Clinical Site — Atlanta, Georgia, United States (RECRUITING)
- Neurocrine Clinical Site — North Canton, Ohio, United States (RECRUITING)
- Neurocrine Clinical Site — Sliven, Bulgaria (RECRUITING)
- Neurocrine Clinical Site — Veliko Tarnovo, Bulgaria (WITHDRAWN)
- Neurocrine Clinical Site — Vratsa, Bulgaria (RECRUITING)
- Neurocrine Clinical Site — Brasov, Romania (RECRUITING)
- Neurocrine Clinical Site — Brasov, Romania (RECRUITING)
- Neurocrine Clinical Site — Bucharest, Romania (RECRUITING)
Study contacts
- Study coordinator: Neurocrine Medical Information Call Center
- Email: medinfo@neurocrine.com
- Phone: 877-641-3461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia