NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient 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, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Overview
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Interventions
- Drug NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description. - Drug Placebo
Placebo will be administered per schedule specified in the arm description.
Primary outcome measures
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5 [Time frame: Baseline, Week 5]
Secondary outcome measures (1)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5 [Time frame: Baseline, Week 5]
Eligibility criteria
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
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
- Participants have 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.
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 · 21 centers
- Neurocrine Clinical Site — Bryant
- Neurocrine Clinical Site — Little Rock
- Neurocrine Clinical Site — Anaheim
- Neurocrine Clinical Site — Pico Rivera
- Neurocrine Clinical Site — San Diego
- Neurocrine Clinical Site — Sherman Oaks
- Neurocrine Clinical Site — Torrance
- Neurocrine Clinical Site — Hollywood
- … and 13 more centers
Identifiers
NCT: NCT06963034 · NBI-1117568-SCZ3029