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-BG
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-12
• Last Update Posted: 26 October 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

Primary Outcome Measures

Name	Time	Method
Main Objective: A study to evaluate the long-term safety and tolerability of flexible doses of LuAF11167 in patients with schizophrenia during the 24-week treatment;Secondary Objective: N/A;Primary end point(s): 1.Number of participants with Treatment-Emergent Adverse Events;Timepoint(s) of evaluation of this end point: 1.[Time Frame: From baseline week 24]

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2. Change in Brief Negative Symptom Scale (BNSS) total score<br>3. Change in Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptoms Factor Score<br>4. Change in PANSS Negative subscale score<br>5. Change in CGI-SCH-S negative symptoms score<br>6. CGI-SCH-DC negative symptoms score<br>7. CGI-SCH-DC negative symptoms response;Timepoint(s) of evaluation of this end point: 2.[Time Frame: from baseline to Week 24]<br>3.[Time Frame: from baseline to Week 24]<br>4.[Time Frame: from baseline to Week 24]<br>5.[Time Frame: from baseline to Week 24]<br>6.[Time Frame: at Week 24]<br>7.[Time Frame: at Week 24]