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

NCT01568216 | Terminated Phase 2

• 2 other identifiers: 201012992011-004844-23
• Study Type: interventional
• Target: 121
• Locations: 7 countries
• Sites: 38

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.

Conditions

Schizophrenia

Keywords

schizophrenia negative symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12

  12 weeks

• Change from baseline to week 12 on the PANSS total score and Marder factor scores

  12 weeks

• Change from baseline to week 12 on the CGI-S

  Week 12

• CGI-I scores at week 12

  12 weeks

• Change on cognition battery

  12 weeks

Study Arms (4)

AMG 747 - Dose 1

EXPERIMENTAL

Drug: AMG 747

AMG 747 - Dose 2

EXPERIMENTAL

Drug: AMG 747

AMG 747 - Dose 3

EXPERIMENTAL

Drug: AMG 747

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AMG 747 DRUG

Three dose levels once-daily oral administration

AMG 747 - Dose 1; AMG 747 - Dose 2; AMG 747 - Dose 3

Placebo DRUG

Once-daily oral administration

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (38)

Research Site

Anaheim, California, 92804, United States

Location

Research Site

Cerritos, California, 90703, United States

Location

Research Site

Culver City, California, 90230, United States

Location

Research Site

Garden Grove, California, 92845, United States

Location

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Los Angeles, California, 90073, United States

Location

Research Site

Norwalk, California, 90650, United States

Location

Research Site

San Bernardino, California, 92408, United States

Location

Research Site

Torrance, California, 90502, United States

Location

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Washington D.C., District of Columbia, 20016, United States

Location

Research Site

North Miami, Florida, 33161, United States

Location

Research Site

Atlanta, Georgia, 30308, United States

Location

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Chicago, Illinois, 60640, United States

Location

Research Site

Marlton, New Jersey, 08053, United States

Location

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Glen Oaks, New York, 11004, United States

Location

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Rochester, New York, 14618, United States

Location

Research Site

Raleigh, North Carolina, 27603, United States

Location

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Dayton, Ohio, 45417, United States

Location

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Houston, Texas, 77008, United States

Location

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Glenside, South Australia, 5065, Australia

Location

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Melbourne, Victoria, 3004, Australia

Location

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Mount Claremont, Western Australia, 6010, Australia

Location

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Calgary, Alberta, T2N 4Z6, Canada

Location

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Penticton, British Columbia, V2A 4M4, Canada

Location

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Kingston, Ontario, K7L 4X3, Canada

Location

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Montreal, Quebec, H3A 1A1, Canada

Location

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Takapuna, Auckland, 1309, New Zealand

Location

Research Site

Khot'kovo, 141371, Russia

Location

Research Site

Moscow, 107076, Russia

Location

Research Site

Moscow, 115552, Russia

Location

Research Site

Saint Petersburg, 192019, Russia

Location

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Saratov, 410028, Russia

Location

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Singapore, 539747, Singapore

Location

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Santander, Cantabria, 39008, Spain

Location

Research Site

Barcelona, Catalonia, 08036, Spain

Location

Research Site

Cornellà de Llobregat, Catalonia, 08940, Spain

Location

Research Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Research Site

Madrid, Madrid, 28009, Spain

Location

Research Site

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 28433500 DERIVED

• 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.

  PMID: 27789188 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Schizophrenia

Interventions

(R)-2-(4-(phenyl(3-(trifluoromethyl)phenyl)methyl)piperazin-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: April 2, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

RU (5); AU (3); SG (1); US (18); NZ (1); CA (4); ES (6)