20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

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: NCT01568216
• Other study ID #: 20101299
• Secondary ID: 2011-004844-23
• Status: Terminated
• Phase: Phase 2
• First received: February 27, 2012
• Last updated: July 8, 2015
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• 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: 121
• Est. completion date: June 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
Australia	Research Site	Glenside	South Australia
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Mt Claremont	Western Australia
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Penticton	British Columbia
New Zealand	Research Site	Takapuna, Auckland
Russian Federation	Research Site	Khotkovo
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint- Petersburg
Russian Federation	Research Site	Saratov
Singapore	Research Site	Singapore
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Cornellá de Llobregat	Cataluña
Spain	Research Site	L'Hospitalet de Llobregat	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Valencia	Comunidad Valenciana
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Cerritos	California
United States	Research Site	Chicago	Illinois
United States	Research Site	Culver City	California
United States	Research Site	Dayton	Ohio
United States	Research Site	Garden Grove	California
United States	Research Site	Glen Oaks	New York
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Marlton	New Jersey
United States	Research Site	North Miami	Florida
United States	Research Site	Norwalk	California
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rochester	New York
United States	Research Site	San Bernardino	California
United States	Research Site	Torrance	California
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Russian Federation,  Singapore,  Spain, 

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)	Week 12	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