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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01568216




Registration number
NCT01568216
Ethics application status
Date submitted
27/02/2012
Date registered
2/04/2012
Date last updated
30/07/2015

Titles & IDs
Public title
20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms
Scientific title
"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms"
Secondary ID [1] 0 0
2011-004844-23
Secondary ID [2] 0 0
20101299
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 747
Treatment: Drugs - Placebo

Experimental: AMG 747 - Dose 1 -

Experimental: AMG 747 - Dose 2 -

Experimental: AMG 747 - Dose 3 -

Placebo Comparator: Placebo Comparator -


Treatment: Drugs: AMG 747
Three dose levels once-daily oral administration

Treatment: Drugs: Placebo
Once-daily oral administration

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Response defined as a = 20% decrease in the NSA-16 total score at week 12 - NSA-16 = 16-item Negative Symptom Assessment Scale
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change from baseline to week 12 on the PANSS total score and Marder factor scores - Positive and Negative Syndrome Scale (PANSS)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Change from baseline to week 12 on the CGI-S - Clinical Global Impression Severity Scale (CGI-S)
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
CGI-I scores at week 12 - Clinical Global Impression Improvement (CGI-I)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change on cognition battery
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Change in personal and social functioning
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Change on patient reported outcomes
Timepoint [7] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Glenside
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Mt Claremont
Recruitment postcode(s) [1] 0 0
5065 - Glenside
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6010 - Mt Claremont
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
New Zealand
State/province [15] 0 0
Takapuna, Auckland
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Khotkovo
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Moscow
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Saint- Petersburg
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Saratov
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Spain
State/province [21] 0 0
Cantabria
Country [22] 0 0
Spain
State/province [22] 0 0
Cataluña
Country [23] 0 0
Spain
State/province [23] 0 0
Comunidad Valenciana
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01568216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01568216