Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Toxic Epidermal Necrolysis)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01568229
First received: February 28, 2012
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: AMG 747
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint


Secondary Outcome Measures:
  • Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    NSA-16 = 16-item Negative Symptom Assessment Scale

  • Change from baseline to week 12 on the PANSS total score and Marder factor scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale (PANSS)

  • Change from baseline to week 12 on the CGI-S [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression Severity Scale (CGI-S)

  • CGI-I scores at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression Improvement (CGI-I)

  • Change on cognition battery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in personal and social functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change on patient reported outcomes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Comparator Drug: Placebo
Once-daily oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568229

  Hide Study Locations
Locations
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72211
Research Site
Springdale, Arkansas, United States, 72764
United States, California
Research Site
Long Beach, California, United States, 90813
Research Site
Oakland, California, United States, 94612
Research Site
Orange, California, United States, 92868
United States, Florida
Research Site
Hialeah, Florida, United States, 33018
Research Site
Kissimmee, Florida, United States, 34741
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30328
United States, Maryland
Research Site
Rockville, Maryland, United States, 20850
United States, Mississippi
Research Site
Flowood, Mississippi, United States, 39232
United States, New Jersey
Research Site
Princeton, New Jersey, United States, 08540
United States, New York
Research Site
Buffalo, New York, United States, 14215
Research Site
New York, New York, United States, 10027
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Research Site
Scranton, Pennsylvania, United States, 18503
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
Dallas, Texas, United States, 75230
Czech Republic
Research Site
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
France
Research Site
Créteil cedex, France, 94010
Research Site
Dôle, France, 39100
Research Site
Montauban cedex, France, 82013
Research Site
Nimes, France, 30029
Malaysia
Research Site
Ipoh, Perak, Malaysia, 30450
Research Site
Ipoh, Perak, Malaysia, 31250
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 55100
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Poland
Research Site
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
United Kingdom
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01568229     History of Changes
Other Study ID Numbers: 20110165, 2011-004845-42
Study First Received: February 28, 2012
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
schizophrenia negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2014