NCT05545111CompletedPhase 2
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
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
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 210 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 4 Oct 2022
- Primary completion date
- 10 Jul 2024
- Lead sponsor
- Neurocrine Biosciences
- Diseases
- Schizophrenia
- NCT number
- NCT05545111
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 210
- From 4 Oct 2022 to the primary completion date, 10 Jul 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
- Positive alcohol test or drug screen for disallowed substances.
Other illness
- An unstable medical condition, chronic disease, or malignancy.
- Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
Other
- Considered by the investigator to be at imminent risk of suicide or injury to self or others.
Who the study is looking for
- Completed informed consent.
- Subject has a primary diagnosis of schizophrenia.
- The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
- Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
- Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | North Canton | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Oakland Park | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Pico Rivera | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Richardson | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Neurocrine Clinical Site Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.