NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Part of paid clinical trials in Culver City, California.

Sponsor
Neurocrine Biosciences
Study ID
NCT07105098
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NBI-1117568 — DRUG
    NBI-1117568 will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo will be administered per schedule specified in the arm description.

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NBI-1117568
    Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.

Primary Outcome Measure

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5 [ Time Frame: Baseline, Week 5 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteCulver CityCalifornia90230-
Neurocrine Clinical SiteGarden GroveCalifornia92845-
Neurocrine Clinical SiteRiversideCalifornia92506-
Neurocrine Clinical SiteAtlantaGeorgia30328-
Neurocrine Clinical SiteNorth CantonOhio44720-

Find similar trials in Culver City, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Culver City, CANeurocrine Clinical Site· Garden Grove, CANeurocrine Clinical Site· Riverside, CANeurocrine Clinical Site· Atlanta, GANeurocrine Clinical Site· North Canton, OH

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