NBI-1117568 for Schizophrenia
Recruiting at 4 trial locations
NM
Overseen ByNeurocrine Medical Information Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Neurocrine Biosciences
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Research Team
CD
Clinical Development Lead
Principal Investigator
Neurocrine Biosciences
Eligibility Criteria
This trial is for adults with a primary diagnosis of schizophrenia who are currently experiencing an acute exacerbation or relapse that requires hospitalization. Participants must be willing to stay inpatient and follow study procedures, and they can't be on prohibited medications like antipsychotics at the start.Inclusion Criteria
I have been diagnosed with schizophrenia.
I am currently having a severe flare-up of my condition that requires hospitalization.
I am not taking any medications that are not allowed in the study.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either NBI-1117568 or placebo once daily orally for 5 weeks
5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- NBI-1117568
Trial Overview The trial is testing NBI-1117568's effectiveness compared to a placebo in improving symptoms of schizophrenia. Patients will either receive the experimental drug or a placebo while staying as inpatients during the study period.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NBI-1117568Experimental Treatment1 Intervention
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
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Who Is Running the Clinical Trial?
Neurocrine Biosciences
Lead Sponsor
Trials
78
Recruited
6,600+
Kyle W. Gano
Neurocrine Biosciences
Chief Executive Officer since 2024
PhD in Pharmacology
Dr. Sanjay Keswani
Neurocrine Biosciences
Chief Medical Officer
MD
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