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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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