Trials / Recruiting
RecruitingNCT07105098
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
A Global, 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-1117568 | NBI-1117568 will be administered per schedule specified in the arm description. |
| DRUG | Placebo | Placebo will be administered per schedule specified in the arm description. |
Timeline
- Start date
- 2025-08-11
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2025-08-05
- Last updated
- 2026-04-15
Locations
11 sites across 3 countries: United States, Bulgaria, Romania
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07105098. Inclusion in this directory is not an endorsement.