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NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurocrine Biosciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Parallel

Treatments tested in this trial

  • NBI-1117568

    Drug

    NBI-1117568 will be administered per schedule specified in the arm description.

  • Placebo

    Drug

    Placebo will be administered per schedule specified in the arm description.

Treatment groups

284 Participants
are divided into 2 treatment groups
Group A: NBI-1117568Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

Time frame
Baseline, Week 5

Secondary outcomes

1

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5

Time frame
Baseline, Week 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neurocrine Biosciences

Lead sponsor

Source ClinicalTrials.gov
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