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

NCT ID: NCT02202213

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg

Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone

Three times daily oral dosing for 14 days.

Group Type: EXPERIMENTAL

Lu AF11167

Intervention Type: DRUG

Matching placebo

Daily oral dosing matching the experimental arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

Lu AF11167

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H.Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials.com

Locations

Parexel International

Glendale, California, United States

Countries

United States

Other Identifiers

15698A

Identifier Type: -

Identifier Source: org_study_id