Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
NCT ID: NCT07288333
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-12-31
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo matched to NBI-1117570.
Placebo
Oral administration
NBI-1117570: Lower-dose
Participants will receive a lower-dose of NBI-1117570.
NBI-1117570
Oral administration
NBI-1117570: Higher-dose
Participants will receive a higher-dose of NBI-1117570.
NBI-1117570
Oral administration
Interventions
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NBI-1117570
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Central Contacts
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Neurocrine Medical Information Call Center
Role: CONTACT
Phone: 1-877-641-3461
Email: [email protected]
Other Identifiers
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2025-521868-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
NBI-1117570-SCZ2035
Identifier Type: -
Identifier Source: org_study_id