NBI-1117570 for adults hospitalized with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional trial testing NBI-1117570 in adults aged 18–55 who are hospitalized for an acute exacerbation of schizophrenia. Eligible participants must have a primary diagnosis of schizophrenia for at least one year and a prior positive response to at least one antipsychotic (other than clozapine); major exclusions include imminent suicide risk, history of seizures, significant cardiovascular disease, pregnancy or breastfeeding, and use of prohibited medications. The investigational drug is compared with placebo during the inpatient stay, with efficacy measured by improvements in behavioral and psychological symptoms. The trial is sponsored by Neurocrine Biosciences and is being run at Neurocrine clinical sites in London and Oxford, UK.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.