Back to results20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMG 747
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia negative symptoms
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AMG 747 - Dose 1
AMG 747 - Dose 2
AMG 747 - Dose 3
Placebo Comparator
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
NSA-16 = 16-item Negative Symptom Assessment Scale
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Positive and Negative Syndrome Scale (PANSS)
Change from baseline to week 12 on the CGI-S
Clinical Global Impression Severity Scale (CGI-S)
CGI-I scores at week 12
Clinical Global Impression Improvement (CGI-I)
Change on cognition battery
Change in personal and social functioning
Change on patient reported outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568216
Brief Title
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
Official Title
"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Toxic Epidermal Necrolysis
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia negative symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 747 - Dose 1
Arm Type
Experimental
Arm Title
AMG 747 - Dose 2
Arm Type
Experimental
Arm Title
AMG 747 - Dose 3
Arm Type
Experimental
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 747
Intervention Description
Three dose levels once-daily oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once-daily oral administration
Primary Outcome Measure Information:
Title
Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
Description
NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12
Description
NSA-16 = 16-item Negative Symptom Assessment Scale
Time Frame
12 weeks
Title
Change from baseline to week 12 on the PANSS total score and Marder factor scores
Description
Positive and Negative Syndrome Scale (PANSS)
Time Frame
12 weeks
Title
Change from baseline to week 12 on the CGI-S
Description
Clinical Global Impression Severity Scale (CGI-S)
Time Frame
Week 12
Title
CGI-I scores at week 12
Description
Clinical Global Impression Improvement (CGI-I)
Time Frame
12 weeks
Title
Change on cognition battery
Time Frame
12 weeks
Title
Change in personal and social functioning
Time Frame
12 weeks
Title
Change on patient reported outcomes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Research Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Research Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Research Site
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Research Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Research Site
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Research Site
City
Glenside
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Mt Claremont
State/Province
Western Australia
ZIP/Postal Code
6010
Country
Australia
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Research Site
City
Takapuna, Auckland
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
Research Site
City
Khotkovo
ZIP/Postal Code
141371
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115552
Country
Russian Federation
Facility Name
Research Site
City
Saint- Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
539747
Country
Singapore
Facility Name
Research Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Cornellá de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08940
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28433500
Citation
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Results Reference
derived
PubMed Identifier
27789188
Citation
Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
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