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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Lu AF11167
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parexel International

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg

Matching placebo

Arm Description

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

Daily oral dosing matching the experimental arm.

Outcomes

Primary Outcome Measures

Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)

Secondary Outcome Measures

Columbia Suicide Severity Rating Scale (C-SSRS)

Full Information

First Posted
July 25, 2014
Last Updated
February 17, 2015
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02202213
Brief Title
Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg
Arm Type
Experimental
Arm Description
Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone Three times daily oral dosing for 14 days.
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral dosing matching the experimental arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Lu AF11167
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Screening to day 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 Other pre-defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H.Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials.com
Official's Role
Study Director
Facility Information:
Facility Name
Parexel International
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States

12. IPD Sharing Statement

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

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