Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

Part of paid clinical trials in Garden Grove, California.

Sponsor
Neurocrine Biosciences
Study ID
NCT07227818
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
    Oral capsules
  • Placebo — DRUG
    Oral capsules

Study Details

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Key Dates

Start date
Dec 16, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

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

Arms

  • Experimental: NBI-1117568
    All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.
  • Placebo Comparator: Placebo
    All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.

Primary Outcome Measure

Time From Randomization to Relapse [ Time Frame: Up to approximately 30 weeks ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteGarden GroveCalifornia92845-
Neurocrine Clinical SiteLa HabraCalifornia90631-
Neurocrine Clinical SiteLemon GroveCalifornia91945-
Neurocrine Clinical SiteOceansideCalifornia92056-
Neurocrine Clinical SiteTorranceCalifornia90504-
Neurocrine Clinical SiteWest HillsCalifornia91307-
Neurocrine Clinical SiteHollywoodFlorida33024-
Neurocrine Clinical SiteMaitlandFlorida32751-
Neurocrine Clinical SiteMiamiFlorida33122-
Neurocrine Clinical SiteMiamiFlorida33155-
Neurocrine Clinical SiteTampaFlorida33629-
Neurocrine Clinical SiteWest Palm BeachFlorida33024-
Neurocrine Clinical SiteAtlantaGeorgia30318-
Neurocrine Clinical SiteBostonMassachusetts02116-
Neurocrine Clinical SiteFlowoodMississippi39232-
Neurocrine Clinical SiteCedarhurstNew York11516-
Neurocrine Clinical SiteNew YorkNew York10029-
Neurocrine Clinical SiteNew YorkNew York10036-
Neurocrine Clinical SiteThe BronxNew York10461-
Neurocrine Clinical SiteBellevueWashington98007-

Find similar trials in Garden Grove, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Garden Grove, CANeurocrine Clinical Site· La Habra, CANeurocrine Clinical Site· Lemon Grove, CANeurocrine Clinical Site· Oceanside, CANeurocrine Clinical Site· Torrance, CANeurocrine Clinical Site· West Hills, CA

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