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drugset / Trial / NCT02892422

Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

NCT02892422 ↗

Phase 3 Completed 528 enrolled H. Lundbeck A/S

NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Timeline

Start: 2016-08
Primary completion: 2019-10-10
Completion: 2019-10-10

Publications

Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lu AF35700	Unknown	10 mg	Oral
Subject	Lu AF35700	Unknown	20 mg	Oral
Subject	Lu AF35700	Unknown	70 mg	Oral

Indications