Schizophrenia
Conditions
Brief summary
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Interventions
DRUGNBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Sponsors
Neurocrine Biosciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Up to 36 months |
Countries
Bulgaria, Romania, Serbia, United States
Contacts
CONTACTNeurocrine Medical Information Call Center
STUDY_DIRECTORClinical Development Lead
Neurocrine Biosciences
Outcome results
None listed