Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Neurocrine Biosciences
Study ID
NCT05545111
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NBI-1117568 — DRUG
    Active treatment with orally administered NBI-1117568
  • Placebo — DRUG
    Placebo matching NBI-1117568

Study Details

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.

Key Dates

Start date
Oct 4, 2022
Status verified
Jul 2025
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024

Study Design

Enrollment
210 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level A
    Participant administered Dose Level A (6 weeks)
  • Experimental: Dose Level B
    Participant administered Dose Level B (6 weeks)
  • Experimental: Dose Level C
    Participant administered Dose Level C (6 weeks)
  • Experimental: Dose Level D
    Participant administered Dose Level D (6 weeks)
  • Placebo Comparator: Placebo Schedule
    Participant administered placebo (6 weeks)

Primary Outcome Measure

Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6 [ Time Frame: Baseline and Week 6 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteLittle RockArkansas72211-
Neurocrine Clinical SiteRogersArkansas72758-
Neurocrine Clinical SiteLemon GroveCalifornia91945-
Neurocrine Clinical SitePico RiveraCalifornia90660-
Neurocrine Clinical SiteSan DiegoCalifornia92123-
Neurocrine Clinical SiteTorranceCalifornia90502-
Neurocrine Clinical SiteMiami LakesFlorida33016-
Neurocrine Clinical SiteOakland ParkFlorida33334-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical siteSt LouisMissouri63141-
Neurocrine Clinical SiteBerlinNew Jersey08053-
Neurocrine Clinical SiteNorth CantonOhio44720-
Neurocrine Clinical SiteAustinTexas78754-
Neurocrine Clinical SiteDeSotoTexas75115-
Neurocrine Clinical SiteRichardsonTexas75080-

Find similar trials in Little Rock, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Little Rock, ARNeurocrine Clinical Site· Rogers, ARNeurocrine Clinical Site· Lemon Grove, CANeurocrine Clinical Site· Pico Rivera, CANeurocrine Clinical Site· San Diego, CANeurocrine Clinical Site· Torrance, CA

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