20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

September 19, 2014 updated by: Amgen

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 615 00
        • Research Site
      • Olomouc, Czech Republic, 779 00
        • Research Site
      • Praha 2, Czech Republic, 120 00
        • Research Site
      • Praha 9, Czech Republic, 190 00
        • Research Site
      • Prerov, Czech Republic, 750 01
        • Research Site
      • Strakonice, Czech Republic, 386 29
        • Research Site
  • France
      • Créteil cedex, France, 94010
        • Research Site
      • Dôle, France, 39100
        • Research Site
      • Montauban cedex, France, 82013
        • Research Site
      • Nimes, France, 30029
        • Research Site
  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Research Site
      • Ipoh, Perak, Malaysia, 31250
        • Research Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
        • Research Site
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • Research Site
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 55100
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-096
        • Research Site
      • Chelmno, Poland, 86-200
        • Research Site
      • Katowice, Poland, 40-340
        • Research Site
      • Skorzewo, Poland, 60-185
        • Research Site
      • Torun, Poland, 87-100
        • Research Site
      • Zuromin, Poland, 09-300
        • Research Site
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Research Site
      • Edinburgh, United Kingdom, EH10 5HF
        • Research Site
      • London, United Kingdom, SE5 8AF
        • Research Site
      • Norwich, United Kingdom, NR1 3RE
        • Research Site
      • Sheffield, United Kingdom, S10 3TH
        • Research Site
      • Warrington, United Kingdom, WA2 8WA
        • Research Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Research Site
      • Springdale, Arkansas, United States, 72764
        • Research Site
    • California
      • Long Beach, California, United States, 90813
        • Research Site
      • Oakland, California, United States, 94612
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Florida
      • Hialeah, Florida, United States, 33018
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Research Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Research Site
    • New York
      • Buffalo, New York, United States, 14215
        • Research Site
      • New York, New York, United States, 10027
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18503
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia
  • Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) ≥ 20
  • Total score on the PANSS Marder Positive Symptom Factor Scale (PSFS) ≤ 30
  • Receiving stable antipsychotic therapy for at least 8 weeks prior to screening
  • Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening
  • Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study
  • The subject or subject's legally acceptable representative has provided informed consent.

Exclusion Criteria:

  • Current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid IQ ≤ 70
  • Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam
  • Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening
  • Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening
  • Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study
  • Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
  • Other criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Drug: Placebo
Once-daily oral administration
Experimental: AMG 747 - Dose 1
Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 2
Drug: AMG 747
Three dose levels once-daily oral administration
Experimental: AMG 747 - Dose 3
Drug: AMG 747
Three dose levels once-daily oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
Time Frame: 12 Weeks
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Time Frame: 12 weeks
Positive and Negative Syndrome Scale (PANSS)
12 weeks
CGI-I scores at week 12
Time Frame: 12 weeks
Clinical Global Impression Improvement (CGI-I)
12 weeks
Change on cognition battery
Time Frame: 12 weeks
12 weeks
Change in personal and social functioning
Time Frame: 12 weeks
12 weeks
Change on patient reported outcomes
Time Frame: 12 weeks
12 weeks
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
Time Frame: 12 Weeks
NSA-16 = 16-item Negative Symptom Assessment Scale
12 Weeks
Change from baseline to week 12 on the CGI-S
Time Frame: 12 weeks
Clinical Global Impression Severity Scale (CGI-S)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110165
  • 2011-004845-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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