A Long-Term Study in Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

Official Title
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Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Pomaglumetad methionil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are clinically diagnosed with schizophrenia Female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control New participants must require initiation of or modification to current antipsychotic treatment, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients. Criterion does not apply to participants rolling over from a feeder study (NCT01328093 and NCT01452919) Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures Participants must be able to understand the nature of the study and have given their own informed consent Exclusion Criteria: Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product (IP) or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil Have any other current psychiatric diagnoses in addition to schizophrenia Have previously completed or withdrawn from this study, or any other study investigating pomaglumetad methionil or any predecessor molecules with glutamatergic activity, except for participants who are rolling over from a feeder study (NCT01328093 and NCT01452919) who will have completed a clinical trial of pomaglumetad methionil Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry Participants who have a history of an inadequate clinical response to antipsychotic treatment for schizophrenia Participants who, for any reason, are considered to be a danger to themselves, or who are actively exhibiting suicidal behaviors Female participants who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study Have known, uncorrected, narrow-angle glaucoma Participants with current or a history of seizure disorder, leucopenia, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses Participants who have had electroconvulsive therapy (ECT) within 3 months of study entry or who will have ECT at any time during the study Participants with known medical history of Human Immunodeficiency Virus (HIV) positive status Participants who test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody Participants with a corrected QT interval (Bazett's; QTcB) >450 msec (male) or >470 msec (female) at study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomaglumetad methionil<br>Pomaglumetad methionil will be administered orally. Participants entering the study will be flexibly dosed between 20 mg, 40 mg, and 80 mg twice daily. | Drug: Pomaglumetad methionil<br>* Administered orally<br>* Other names: LY2140023;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS) |  | Baseline, up to 5 years | 
| Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS) |  | Baseline, up to 5 years | 
| Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS) |  | Baseline, up to 5 years | 
| Proportion of participants with clinically significant weight change from baseline up to 5 years |  | Baseline up to 5 years | 
| Categorical change from baseline up to 5 years in prolactin level |  | Baseline, up to 5 years | 
| Categorical change from baseline up to 5 years in fasting glucose and lipids |  | Baseline, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to lack of efficacy |  | Baseline up to 5 years | 
| Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) |  | Baseline up to 5 years | 
| Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S) |  | Baseline, up to 5 years | 
| Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS) |  | Baseline, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, LY2140023, pomaglumetad methionil