Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With Schizophrenia

Summary

A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with schizophrenia

Timeline

Start

2018-12-27

Primary completion

2020-08-20

Completion

2020-09-03

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy based on interim analysis”

paper Double-blind treatment with Lu AF11167 3-4mg was not superior to placebo in the reduction of Brief Negative Symptom Scale (BNSS) total scores PMID 35704951 ↗

paper Treatment with Lu AF11167 1-2mg also failed to separate from placebo on the primary endpoint. PMID 35704951 ↗

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	1 mg	Oral
Subject	Lu AF11167	Unknown	2 mg	Oral
Subject	Lu AF11167	Unknown	3 mg	Oral
Subject	Lu AF11167	Unknown	4 mg	Oral

Indications