Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
Public ClinicalTrials.gov record NCT05545111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.
Study identification
- NCT ID
- NCT05545111
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2022 (Actual)
- Primary completion
- Jul 10, 2024 (Actual)
- Completion
- Jul 10, 2024 (Actual)
- Last update posted
- Jul 11, 2025
2022 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurocrine Clinical Site | Little Rock | Arkansas | 72211 | — |
| Neurocrine Clinical Site | Rogers | Arkansas | 72758 | — |
| Neurocrine Clinical Site | Lemon Grove | California | 91945 | — |
| Neurocrine Clinical Site | Pico Rivera | California | 90660 | — |
| Neurocrine Clinical Site | San Diego | California | 92123 | — |
| Neurocrine Clinical Site | Torrance | California | 90502 | — |
| Neurocrine Clinical Site | Miami Lakes | Florida | 33016 | — |
| Neurocrine Clinical Site | Oakland Park | Florida | 33334 | — |
| Neurocrine Clinical Site | Gaithersburg | Maryland | 20877 | — |
| Neurocrine Clinical site | St Louis | Missouri | 63141 | — |
| Neurocrine Clinical Site | Berlin | New Jersey | 08053 | — |
| Neurocrine Clinical Site | North Canton | Ohio | 44720 | — |
| Neurocrine Clinical Site | Austin | Texas | 78754 | — |
| Neurocrine Clinical Site | DeSoto | Texas | 75115 | — |
| Neurocrine Clinical Site | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05545111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 11, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05545111 live on ClinicalTrials.gov.