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
1 other identifier
interventional
210
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Oct 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2024
CompletedJuly 11, 2025
July 1, 2025
1.8 years
September 14, 2022
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
Baseline and Week 6
Study Arms (5)
Dose Level A
EXPERIMENTALParticipant administered Dose Level A (6 weeks)
Dose Level B
EXPERIMENTALParticipant administered Dose Level B (6 weeks)
Dose Level C
EXPERIMENTALParticipant administered Dose Level C (6 weeks)
Dose Level D
EXPERIMENTALParticipant administered Dose Level D (6 weeks)
Placebo Schedule
PLACEBO COMPARATORParticipant administered placebo (6 weeks)
Interventions
Active treatment with orally administered NBI-1117568
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- An unstable medical condition, chronic disease, or malignancy.
- Considered by the investigator to be at imminent risk of suicide or injury to self or others.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Neurocrine Clinical Site
Little Rock, Arkansas, 72211, United States
Neurocrine Clinical Site
Rogers, Arkansas, 72758, United States
Neurocrine Clinical Site
Lemon Grove, California, 91945, United States
Neurocrine Clinical Site
Pico Rivera, California, 90660, United States
Neurocrine Clinical Site
San Diego, California, 92123, United States
Neurocrine Clinical Site
Torrance, California, 90502, United States
Neurocrine Clinical Site
Miami Lakes, Florida, 33016, United States
Neurocrine Clinical Site
Oakland Park, Florida, 33334, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877, United States
Neurocrine Clinical site
St Louis, Missouri, 63141, United States
Neurocrine Clinical Site
Berlin, New Jersey, 08053, United States
Neurocrine Clinical Site
North Canton, Ohio, 44720, United States
Neurocrine Clinical Site
Austin, Texas, 78754, United States
Neurocrine Clinical Site
DeSoto, Texas, 75115, United States
Neurocrine Clinical Site
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 19, 2022
Study Start
October 4, 2022
Primary Completion
July 10, 2024
Study Completion
July 10, 2024
Last Updated
July 11, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share