Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1117570, Placebo.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria, Romania, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Overview
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.
Interventions
- Drug NBI-1117570
Oral administration - Drug Placebo
Oral administration
Primary outcome measures
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35 [Time frame: Day 35]
Secondary outcome measures (1)
- Number of Participants With Treatment-emergent Adverse Event (TEAEs) [Time frame: Day 1 up to Day 49]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Bulgaria · 3 centers
- Neurocrine Clinical Site — Kazanlak
- Neurocrine Clinical Site — Pazardzhik
- Neurocrine Clinical Site — Targovishte
United Kingdom · 2 centers
- Neurocrine Clinical Site — London
- Neurocrine Clinical Site — Oxford
Romania · 1 center
- Neurocrine Clinical Site — Târgu Mureş
Identifiers
NCT: NCT07288333 · NBI-1117570-SCZ2035 · 2025-521868-35-00