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

StatusRecruiting
PhasePhase 3
Started2025-12-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
minor
Trial sites expanded: 20 → 25 locations
2026-06-04
minor
Study Status, Contacts/Locations v3
Study sites18→20
2026-05-13
minor
Study Status, Contacts/Locations v2
Study sites17→18
2026-04-10
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12→confirmed 2025-12-16
Study sites0→17
2025-11-11
minor
Original filing
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.
Trial Details
NCT Number NCT07227818
Lead Sponsor Neurocrine Biosciences
Conditions Schizophrenia
Enrollment 560 participants
Start Date 2025-12-16
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-25