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

NCT02202213 | Completed Phase 1

• 1 other identifier: 15698A
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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)

  Screnning to day 25

Secondary Outcomes (1)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Screening to day 25

Study Arms (2)

Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg

EXPERIMENTAL

Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone Three times daily oral dosing for 14 days.

Drug: Lu AF11167

Matching placebo

PLACEBO COMPARATOR

Daily oral dosing matching the experimental arm.

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo

Lu AF11167 DRUG

Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Parexel International

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Email contact via H.Lundbeck A/S

  LundbeckClinicalTrials.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 28, 2014
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

US (1)