NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurocrine Biosciences
About this trial
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
NBI-1117568
DrugNBI-1117568 will be administered per schedule specified in the arm description.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: NBI-1117568Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-emergent Adverse Events
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov