NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Recruiting · NCT07105098 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurocrine Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
NBI-1117568Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
15 locations listed across 3 US states.
- Neurocrine Clinical Site - Culver City, California, United States
- Neurocrine Clinical Site - Garden Grove, California, United States
- Neurocrine Clinical Site - Riverside, California, United States
- Neurocrine Clinical Site - Atlanta, Georgia, United States
- Neurocrine Clinical Site - North Canton, Ohio, United States
- Neurocrine Clinical Site - Belgrade, Serbia
- Neurocrine Clinical Site - Brasov, Romania
- Neurocrine Clinical Site - Brasov, Romania
- Neurocrine Clinical Site - Bucharest, Romania
- Neurocrine Clinical Site - Gornja Toponica, Serbia
- Neurocrine Clinical Site - Győr, Hungary
- Neurocrine Clinical Site - Kragujevac, Serbia
- Neurocrine Clinical Site - Sliven, Bulgaria
- Neurocrine Clinical Site - Veliko Tarnovo, Bulgaria
- Neurocrine Clinical Site - Vratsa, Bulgaria