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

• ClinicalTrials.gov Identifier: NCT02202213
• Recruitment Status: Completed
• First Posted: July 28, 2014
• Last Update Posted: February 18, 2015
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Placebo; Drug: Lu AF11167	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2013
• Actual Primary Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Lu AF11167
Placebo Comparator: Matching placebo; Daily oral dosing matching the experimental arm.	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG) [ Time Frame: Screnning to day 25 ]

Secondary Outcome Measures :

1. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Screening to day 25 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Other pre-defined inclusion and exclusion criteria may apply

Contacts and Locations

Locations

United States, California

Parexel International

Glendale, California, United States, 91206

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H.Lundbeck A/S; LundbeckClinicalTrials.com

More Information

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT02202213
• Other Study ID Numbers: 15698A
• First Posted: July 28, 2014
• Last Update Posted: February 18, 2015
• Last Verified: February 2015

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders