Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
Recruiting · NCT07288333 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurocrine Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
NBI-1117570Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
6 locations listed.
- Neurocrine Clinical Site - Kazanlak, Bulgaria
- Neurocrine Clinical Site - London, United Kingdom
- Neurocrine Clinical Site - Oxford, United Kingdom
- Neurocrine Clinical Site - Pazardzhik, Bulgaria
- Neurocrine Clinical Site - Targovishte, Bulgaria
- Neurocrine Clinical Site - Târgu Mureş, Romania