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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01568229
• Other study ID #: 20110165
• Secondary ID: 2011-004845-42
• Status: Terminated
• Phase: Phase 2
• First received: February 28, 2012
• Last updated: September 19, 2014
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• AMG 747
Three dose levels once-daily oral administration
• Placebo
Once-daily oral administration

Locations

Country	Name	City	State
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 9
Czech Republic	Research Site	Prerov
Czech Republic	Research Site	Strakonice
France	Research Site	Créteil cedex
France	Research Site	Dôle
France	Research Site	Montauban cedex
France	Research Site	Nimes
Malaysia	Research Site	Ipoh	Perak
Malaysia	Research Site	Ipoh	Perak
Malaysia	Research Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Research Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Research Site	Kuala Lumpur	Wilayah Persekutuan
Poland	Research Site	Bydgoszcz
Poland	Research Site	Chelmno
Poland	Research Site	Katowice
Poland	Research Site	Skorzewo
Poland	Research Site	Torun
Poland	Research Site	Zuromin
United Kingdom	Research Site	Barnet
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Warrington
United States	Research Site	Atlanta	Georgia
United States	Research Site	Buffalo	New York
United States	Research Site	Dallas	Texas
United States	Research Site	Durham	North Carolina
United States	Research Site	Flowood	Mississippi
United States	Research Site	Hialeah	Florida
United States	Research Site	Kissimmee	Florida
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Oakland	California
United States	Research Site	Orange	California
United States	Research Site	Princeton	New Jersey
United States	Research Site	Rockville	Maryland
United States	Research Site	Scranton	Pennsylvania
United States	Research Site	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Czech Republic,  France,  Malaysia,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score	NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint	12 Weeks	No
Secondary	Response defined as a = 20% decrease in the NSA-16 total score at week 12	NSA-16 = 16-item Negative Symptom Assessment Scale	12 Weeks	No
Secondary	Change from baseline to week 12 on the PANSS total score and Marder factor scores	Positive and Negative Syndrome Scale (PANSS)	12 weeks	No
Secondary	Change from baseline to week 12 on the CGI-S	Clinical Global Impression Severity Scale (CGI-S)	12 weeks	No
Secondary	CGI-I scores at week 12	Clinical Global Impression Improvement (CGI-I)	12 weeks	No
Secondary	Change on cognition battery		12 weeks	No
Secondary	Change in personal and social functioning		12 weeks	No
Secondary	Change on patient reported outcomes		12 weeks	No

External Links

•   AmgenTrials clinical trials website