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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Lu AF11167

• Registration Number: NCT02202213
• Lead Sponsor: H. Lundbeck A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Placebo	Daily oral dosing matching the experimental arm.
Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg	Lu AF11167	Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone Three times daily oral dosing for 14 days.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Columbia Suicide Severity Rating Scale (C-SSRS)	Screening to day 25

Trial Locations

Locations (1)

Parexel International; 🇺🇸 Glendale, California, United States