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

Phase 1

• Conditions: schizophrenia with persistent prominent negative symptoms; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-002708-15-CZ
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-28
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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.

Other inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified