NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
- Registration Number
- NCT07114874
- Lead Sponsor
- Neurocrine Biosciences
- Brief Summary
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
- Participant has a primary diagnosis of schizophrenia
- Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
- Participant must reside in a stable housing situation
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NBI-1117568 NBI-1117568 Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events Up to 36 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neurocrine Clinical Site
🇺🇸San Diego, California, United States
Neurocrine Clinical Site🇺🇸San Diego, California, United States