Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Pomaglumetad methionil
Product Code: LY2140023
Pharmaceutical Form: Tablet
INN or Proposed INN: Pomaglumetad methionil
CAS Number: 635318-55-7
Current Sponsor code: LY2140023
Concentrat
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients are male or female, 18 to 65 years of age (inclusive) at study entry with a diagnosis of schizophrenia as defined in the DSM-IV-TR (APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; Residual 295.60; or Undifferentiated, 295.90) and confirmed by the SCID. Patients who roll over from a feeder study are 18 to 65 years of age (inclusive) at time of entry into the feeder study, and no confirmatory diagnostic scale is needed. •Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control. •In the opinion of the investigator, at Visit 1, new patients 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 patients rolling over from a feeder study. •Patients 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. •Patients must be able to understand the nature of the study and have given their own informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 282 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an 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 patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil. •Are investigator site personnel directly affiliated with this study and/or their immediate families. •Are Lilly employees. •Are hospitalized within 2 weeks of Visit 1 or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months. For patients rolling over from a feeder study who are hospitalized within 2 weeks of rollover, contact sponsor to determine eligibility. •Have any other current Axis I psychiatric diagnoses (as defined in DSM-IV-TR) 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 patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil. •Patients 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 Visit 1, or who have received any clozapine at all during the month before Visit 1. •Patients who have a history of an inadequate clinical response, in the opinion of the investigator, to antipsychotic treatment for schizophrenia. •Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed. •Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1. •In the clinician's judgment, patients who, for any reason, are considered to be a danger to themselves, or who have answered “yes” to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C-SSRS; and the ideation or behavior occurred within the past month. •DSM-IV-TR diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1. •Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 (or at any time during the study). •Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study. •Have known, uncorrected, narrow-angle glaucoma. •Have a history of one or more seizures. •Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study. •Patients with untreated hyper- or hypothyroidism. •Have leukopenia (white blood cells [WBC] <3500/mm3, or <3.5 GI/L, or <3.5 103/uL) or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis (absolute neutrophil count <500/mm3, or <0.5 GI/L, or <0.5 103/uL) during the patient’s lifetime. •Patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open-label, single-arm study is to evaluate the long-term safety of Pomaglumetad Methionil (LY2140023) given orally in flexible doses (20 mg, 40 mg, and 80 mg BID) in patients with schizophrenia by monitoring EPS, as evaluated by the Barnes Akathisia Scale (Barnes), the Simpson-Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS); weight; prolactin; and the following metabolic parameters: fasting glucose, total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and total triglycerides.;Secondary Objective: To evaluate the safety and tolerability of Pomaglumetad methionil (LY2140023), as measured by the following: o TEAEs, o electrocardiograms (ECGs), o neurological examination, o vital signs and laboratory tests, and o solicited questioning of suicide-related AEs (behavior and ideations) using the Columbia-Suicide Severity Rating Scale (C-SSRS). • to evaluate the long-term efficacy of LY2140023 in patients diagnosed with schizophrenia as measured by Clinical Global Impressions-Severity (CGI-S), Brief Psychiatric Rating Scale (BPRS), and time to discontinuation due to lack of efficacy or initiation of an adjunctive antipsychotic treatment. • to evaluate the long-term safety of LY2140023 in a prospectively defined subpopulation. ;Timepoint(s) of evaluation of this end point: Patient Groups: A:All enrolled patients B:Patients grouped by feeder study C:New patients who enrolled and were not from any feeder study Groups above will be presented in each analysis sets below. Pomaglumetad Methionil Monotherapy:Baseline will be Visit 1 assessment and endpoint will be the last measurement in the study, or last measurement prior to receiving adjunctive therapy, whichever comes first.Pomaglumetad Methionil & Adjunctive Antipsychotic Treatment:Baseline for these analyses will be the last assessment prior to receiving adjunctive antipsychotic treatment and en | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To evaluate the safety and tolerability of pomaglumetad methionil as measured by the following: treatment-emergent adverse events (TEAEs), electrocardiograms (ECGs), neurological examination, vital signs and laboratory tests, and solicited questioning of suicide-related adverse events (AEs) (behavior and ideations) using the Columbia-Suicide Severity Rating Scale (C-SSRS). •To evaluate the long-term efficacy of pomaglumetad methionil.Efficacy analyses will be conducted for all analysis groups within each analysis set.The efficacy variables will include change from baseline in CGI-S and BPRS total score as well as BPRS positive, BPRS negative, and BPRS anxiety-depression domains.Mean change from baseline to each postbaseline visit will be analyzed using an MMRM analysis, including terms for baseline, visit, and investigator site for the Pomaglumetad Methionil Monotherapy and All Pomaglumetad Methionil Patients analysis sets. For the Pomaglumetad Methionil and Adjunctive Antipsychotic Treatment analysis set, the model will include terms for baseline, month on adjunctive therapy, and investigator site. A Kaplan-Meier time to either discontinuation due to lack of efficacy or initiation of an adjunctive antipsychotic treatment (whichever comes first for a patient) plot will be created.No p-value will be generated. •To evaluate the long-term safety of pomaglumetad methionil in a prospectively defined subpopulation. ;Timepoint(s) of evaluation of this end point: Patient Groups: A:All enrolled patients B:Patients grouped by feeder study C:New patients who enrolled and were not from any feeder study Groups above will be presented in each analysis sets below. Pomaglumetad Methionil Monotherapy:Baseline will be Visit 1 assessment and endpoint will be the last measurement in the study, or last measurement prior to receiving adjunctive therapy, whichever comes first.Pomaglumetad Methionil & Adjunctive Antipsychotic Treatment:Baseline for these analys | — |
Countries
Austria, Belgium, Brazil, France, Germany, Greece, Poland, Romania, Spain, Sweden, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed