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A Long-Term Study in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01487083
Recruitment Status : Terminated (The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
First Posted : December 7, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pomaglumetad methionil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia
Study Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pomaglumetad methionil
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
Administered orally
Other Name: LY2140023


Outcome Measures
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Primary Outcome Measures :
  1. Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 5 years ]
  2. Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 5 years ]
  3. Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 5 years ]
  4. Proportion of participants with clinically significant weight change from baseline up to 5 years [ Time Frame: Baseline up to 5 years ]
  5. Categorical change from baseline up to 5 years in prolactin level [ Time Frame: Baseline, up to 5 years ]
  6. Categorical change from baseline up to 5 years in fasting glucose and lipids [ Time Frame: Baseline, up to 5 years ]

Secondary Outcome Measures :
  1. Time to lack of efficacy [ Time Frame: Baseline up to 5 years ]
  2. Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline up to 5 years ]
  3. Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline, up to 5 years ]
  4. Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS) [ Time Frame: Baseline, up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487083


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Locations
United States, California
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Cerritos, California, United States, 90703
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Escondido, California, United States, 92025
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Garden Grove, California, United States, 92845
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Long Beach, California, United States, 90813
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San Diego, California, United States, 92123
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Sherman Oaks, California, United States, 91403
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Torrance, California, United States, 90502
United States, District of Columbia
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Washington, District of Columbia, United States, 20016
United States, Florida
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Coral Gables, Florida, United States, 33145
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Lauderhill, Florida, United States, 33319
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Maitland, Florida, United States, 32751
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North Miami, Florida, United States, 33161
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Oakland Park, Florida, United States, 33334
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Sanford, Florida, United States, 32771
United States, Illinois
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Chicago, Illinois, United States, 60640
United States, Indiana
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Indianapolis, Indiana, United States, 46260
United States, Louisiana
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Lake Charles, Louisiana, United States, 70629
United States, Mississippi
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Flowood, Mississippi, United States, 39232
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
United States, New Jersey
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Marlton, New Jersey, United States, 08053
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Princeton, New Jersey, United States, 08540
United States, New York
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Brooklyn, New York, United States, 11235
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Cedarhurst, New York, United States, 11516
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Fresh Meadows, New York, United States, 11366
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Rochester, New York, United States, 14615
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Staten Island, New York, United States, 10312
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
United States, Ohio
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Beachwood, Ohio, United States, 44122
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18104
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Philadelphia, Pennsylvania, United States, 19139
United States, Texas
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Austin, Texas, United States, 78754
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Desoto, Texas, United States, 75115
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Wharton, Texas, United States, 77488
United States, Virginia
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Richmond, Virginia, United States, 23230
Austria
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Vienna, Austria, 1010
Brazil
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Salvador, Brazil, 40301500
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São Paulo, Brazil, 22270-060
France
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Limoges, France, 87025
Germany
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Dresden, Germany, 01307
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Oranienburg, Germany, 16515
Greece
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Haidari, Greece, 12462
Poland
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Bialystok, Poland, 15-879
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Gdynia, Poland, 81-361
Puerto Rico
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San Juan, Puerto Rico, 00926
Romania
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Bucharest, Romania, 041914
Spain
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Madrid, Spain, 28031
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Vic, Spain, 08500
Sweden
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Lulea, Sweden, SE 972 35
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Malmo, Sweden, 21153
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01487083     History of Changes
Other Study ID Numbers: 12666
H8Y-MC-HBBV ( Other Identifier: Eli Lilly and Company )
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: November 2012

Keywords provided by Eli Lilly and Company:
schizophrenia
LY2140023
pomaglumetad methionil

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders