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NBI-1117568 in Preventing Relapse of Schizophrenia
NCT07227818Phase 3
Key facts
- Status
- Recruiting
- Start
- Dec 2025
- Primary completion
- Jul 2029
- Countries
- 3
- Sponsor
- Neurocrine Biosciences
- Modality
- Small Molecules
- Drugs
- direclidine
- Conditions
- schizophrenia
01
Overview
Phase 3, randomised, double-blind trial in schizophrenia comparing NBI-1117568 with Placebo (2 arms). Primary endpoint: Time From Randomization to Relapse at 30 weeks. Started Dec 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NBI-1117568
Participants receive NBI-1117568 during the Double-blind Treatment Period.
Placebo
Participants receive placebo matching NBI-1117568 during the Double-blind Treatment Period.
03
Who it enrols
Adults with a primary diagnosis of schizophrenia for at least 1 year, who have had a positive response to at least one prior antipsychotic therapy (excluding clozapine), and no unstable medical conditions or recent long-term psychiatric hospitalizations.
04
Endpoints
Primary
Time From Randomization to Relapse
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