Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNeurocrine Biosciences
About this trial
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 55 years of age
Primary diagnosis of schizophrenia ≥1 year before screening.
Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.
Disqualifiers
Considered to be at imminent risk of suicide or injury to self or others.
History of epilepsy, seizures, or convulsions.
Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.
Currently taking prohibited medications.
Trial design
Design model
Parallel
Treatments tested in this trial
NBI-1117570
DrugOral administration
Placebo
DrugOral administration
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: NBI-1117570: Lower-doseExperimental treatment 1 intervention
Group B: NBI-1117570: Higher-doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Time frame
Day 35Secondary outcomes
1
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Time frame
Day 1 up to Day 49Sponsors and contacts
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Source ClinicalTrials.gov