Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Interventional, Randomised, Double-blind, Placebo Controlled, Multiple-dose Study Investigating the Safety, Tolerability, PK and PD Properties of Lu AF11167 in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202213
• Other study ID #: 15698A
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2014
• Last updated: February 17, 2015
• Start date: October 2013

Study information

• Verified date: February 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as added treatment to risperidone).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Man or woman aged =18 years and =60 years with a body mass index (BMI) of =18.5 and =38 m2

• Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)

• Clinical Global Impression - Severity of Illness (CGI-S) score =4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)

• PANSS total score =80 at the Screening Visit and the Baseline Visit (Day -1)

• Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)

• Minimal level of extrapyramidal signs, defined as a score =5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit

• Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)

Exclusion Criteria:

• The patient experienced an acute exacerbation requiring hospitalization within the last 6 months

• The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks

Other pre-defined inclusion and exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Placebo

• Lu AF11167

Locations

Country	Name	City	State
United States	Parexel International	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)		Screnning to day 25	Yes
Secondary	Columbia Suicide Severity Rating Scale (C-SSRS)		Screening to day 25	Yes