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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.
* Pregnant or lactating.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Primary outcome measure(s)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35 — Day 35
Trial sites (6)
Facility
City
Region
Status
Neurocrine Clinical Site
Kazanlak
Bulgaria
Recruiting
Neurocrine Clinical Site
Pazardzhik
Bulgaria
Recruiting
Neurocrine Clinical Site
Targovishte
Bulgaria
Recruiting
Neurocrine Clinical Site
Târgu Mureş
Romania
Recruiting
Neurocrine Clinical Site
London
United Kingdom
Recruiting
Neurocrine Clinical Site
Oxford
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.