--- title: "NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia" nct_id: NCT06963034 overall_status: RECRUITING phase: PHASE3 sponsor: Neurocrine Biosciences study_type: INTERVENTIONAL primary_condition: Schizophrenia countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06963034.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06963034" ct_last_update_post_date: 2026-03-06 last_seen_at: "2026-05-12T07:22:50.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia **Official Title:** A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization **NCT ID:** [NCT06963034](https://clinicaltrials.gov/study/NCT06963034) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 284 - **Lead Sponsor:** Neurocrine Biosciences - **Conditions:** Schizophrenia - **Start Date:** 2025-05-08 - **Completion Date:** 2027-10 - **CT.gov Last Update:** 2026-03-06 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568. * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply. ``` ## Arms - **NBI-1117568** (EXPERIMENTAL) — Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks. - **Placebo** (PLACEBO_COMPARATOR) — Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks. ## 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. ## Primary Outcomes - **Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5** _(time frame: Baseline, Week 5)_ ## Secondary Outcomes - **Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5** _(time frame: Baseline, Week 5)_ ## Locations (21) - Neurocrine Clinical Site, Bryant, Arkansas, United States — _RECRUITING_ - Neurocrine Clinical Site, Little Rock, Arkansas, United States — _RECRUITING_ - Neurocrine Clinical Site, Anaheim, California, United States — _RECRUITING_ - Neurocrine Clinical Site, Pico Rivera, California, United States — _RECRUITING_ - Neurocrine Clinical Site, San Diego, California, United States — _RECRUITING_ - Neurocrine Clinical Site, Sherman Oaks, California, United States — _RECRUITING_ - Neurocrine Clinical Site, Torrance, California, United States — _RECRUITING_ - Neurocrine Clinical Site, Hollywood, Florida, United States — _RECRUITING_ - Neurocrine Clinical Site, Miami Lakes, Florida, United States — _RECRUITING_ - Neurocrine Clinical Site, Atlanta, Georgia, United States — _RECRUITING_ - Neurocrine Clinical Site, Decatur, Georgia, United States — _RECRUITING_ - Neurocrine Clinical Site, Snellville, Georgia, United States — _RECRUITING_ - Neurocrine Clinical Site, Chicago, Illinois, United States — _RECRUITING_ - Neurocrine Clinical Site, Gaithersburg, Maryland, United States — _RECRUITING_ - Neurocrine Clinical Site, Watertown, Massachusetts, United States — _RECRUITING_ - Neurocrine Clinical Site, Marlton, New Jersey, United States — _RECRUITING_ - Neurocrine Clinical Site, Staten Island, New York, United States — _RECRUITING_ - Neurocrine Clinical Site, The Bronx, New York, United States — _RECRUITING_ - Neurocrine Clinical Site, Austin, Texas, United States — _RECRUITING_ - Neurocrine Clinical Site, DeSoto, Texas, United States — _RECRUITING_ - Neurocrine Clinical Site, Houston, Texas, United States — _RECRUITING_ ## Recent Field Changes (last 30 days) - `outcomes.secondary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.neurocrine clinical site|bryant|arkansas|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|anaheim|california|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|pico rivera|california|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|san diego|california|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|sherman oaks|california|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|torrance|california|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|hollywood|florida|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|miami lakes|florida|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|decatur|georgia|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|snellville|georgia|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|gaithersburg|maryland|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|watertown|massachusetts|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|marlton|new jersey|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|staten island|new york|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|the bronx|new york|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|austin|texas|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|desoto|texas|united states` — added _(2026-05-12)_ - `locations.neurocrine clinical site|houston|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06963034.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06963034* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*