NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Part of paid clinical trials in Bryant, Arkansas.

Sponsor
Neurocrine Biosciences
Study ID
NCT06963034
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
May 8, 2025
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 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 (21)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteBryantArkansas72022-
Neurocrine Clinical SiteLittle RockArkansas72211-
Neurocrine Clinical SiteAnaheimCalifornia92805-
Neurocrine Clinical SitePico RiveraCalifornia90660-
Neurocrine Clinical SiteSan DiegoCalifornia92123-
Neurocrine Clinical SiteSherman OaksCalifornia91403-
Neurocrine Clinical SiteTorranceCalifornia90504-
Neurocrine Clinical SiteHollywoodFlorida33024-
Neurocrine Clinical SiteMiami LakesFlorida33016-
Neurocrine Clinical SiteAtlantaGeorgia30331-
Neurocrine Clinical SiteDecaturGeorgia30030-
Neurocrine Clinical SiteSnellvilleGeorgia30078-
Neurocrine Clinical SiteChicagoIllinois60640-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical SiteWatertownMassachusetts02472-
Neurocrine Clinical SiteMarltonNew Jersey08053-
Neurocrine Clinical SiteStaten IslandNew York10314-
Neurocrine Clinical SiteThe BronxNew York10461-
Neurocrine Clinical SiteAustinTexas78754-
Neurocrine Clinical SiteDeSotoTexas75115-
Neurocrine Clinical SiteHoustonTexas77043-

Find similar trials in Bryant, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Bryant, ARNeurocrine Clinical Site· Little Rock, ARNeurocrine Clinical Site· Anaheim, CANeurocrine Clinical Site· Pico Rivera, CANeurocrine Clinical Site· San Diego, CANeurocrine Clinical Site· Sherman Oaks, CA

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