Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative Symptoms

Phase 2 Terminated 96 enrolled H. Lundbeck A/S

NaSingle-groupOpen-labelTreatment

Summary

A study to evaluate the long-term safety and tolerability of flexible doses of Lu AF11167 in patients with schizophrenia during the 24-week treatment period

Timeline

Start: 2019-04-22
Primary completion: 2020-09-01
Completion: 2020-09-14

Outcome

Outcome not reported

Stopped: “Lack of efficacy based on the interim analysis in the 17972A study”

Publications

Meyer-Lindenberg A, Nielsen J, Such P, Lemming OM, Zambori J, Buller R, der Goltz CV. A double-blind, randomized, placebo-controlled proof of concept study of the efficacy and safety of Lu AF11167 for persistent negative symptoms in people with schizophrenia. Eur Neuropsychopharmacol. 2022 Aug;61:4-14. doi: 10.1016/j.euroneuro.2022.05.009. Epub 2022 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lu AF11167	Unknown	2 mg	Oral
Subject	Lu AF11167	Unknown	4 mg	Oral