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

Lundbeck

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Lu AF11167

Study type: Interventional

Funder types: Industry

Identifiers

NCT03929497

17972B

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient completed Study 17972A.
• The patient and the patient's caregiver or identified responsible person is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific for Study 17972B.
• The patient can potentially benefit from 24 weeks of treatment with Lu AF11167 according to the investigator's clinical judgment.

Exclusion criteria

• The patient has any current primary psychiatric disorder other than schizophrenia diagnosed during study 17972A
• The patient, in the opinion of the investigator, is at significant risk of suicide

Other in- and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Lu AF11167

Experimental group

Treatment:

Drug: Lu AF11167