NCT01487083

Brief Summary

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

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
11 countries

51 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

November 30, 2011

Last Update Submit

January 11, 2013

Conditions

Schizophrenia

Keywords

schizophreniaLY2140023pomaglumetad methionil

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Pomaglumetad methionil

EXPERIMENTAL

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

Interventions

Pomaglumetad methionilDRUG

Administered orally

Also known as: LY2140023
Pomaglumetad methionil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cerritos, California, 90703, United States

Location

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Escondido, California, 92025, United States

Location

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Garden Grove, California, 92845, United States

Location

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Long Beach, California, 90813, United States

Location

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San Diego, California, 92123, United States

Location

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Sherman Oaks, California, 91403, United States

Location

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Torrance, California, 90502, United States

Location

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

Location

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Coral Gables, Florida, 33145, United States

Location

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Lauderhill, Florida, 33319, United States

Location

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Maitland, Florida, 32751, United States

Location

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North Miami, Florida, 33161, United States

Location

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Oakland Park, Florida, 33334, United States

Location

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Sanford, Florida, 32771, United States

Location

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Chicago, Illinois, 60640, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Lake Charles, Louisiana, 70629, United States

Location

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Flowood, Mississippi, 39232, United States

Location

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Creve Coeur, Missouri, 63141, United States

Location

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Marlton, New Jersey, 08053, United States

Location

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Princeton, New Jersey, 08540, United States

Location

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Brooklyn, New York, 11235, United States

Location

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Cedarhurst, New York, 11516, United States

Location

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Fresh Meadows, New York, 11366, United States

Location

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Rochester, New York, 14615, United States

Location

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Staten Island, New York, 10312, United States

Location

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Charlotte, North Carolina, 28211, United States

Location

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Beachwood, Ohio, 44122, United States

Location

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Oklahoma City, Oklahoma, 73103, United States

Location

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Eugene, Oregon, 97401, United States

Location

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Allentown, Pennsylvania, 18104, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Austin, Texas, 78754, United States

Location

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DeSoto, Texas, 75115, United States

Location

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Wharton, Texas, 77488, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Vienna, 1010, Austria

Location

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Salvador, 40301500, Brazil

Location

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São Paulo, 22270-060, Brazil

Location

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Limoges, 87025, France

Location

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Dresden, 01307, Germany

Location

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Oranienburg, 16515, Germany

Location

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Haidari, 12462, Greece

Location

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Bialystok, 15-879, Poland

Location

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Gdynia, 81-361, Poland

Location

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San Juan, 00926, Puerto Rico

Location

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Bucharest, 041914, Romania

Location

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Madrid, 28031, Spain

Location

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Vic, 08500, Spain

Location

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Luleå, SE 972 35, Sweden

Location

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Malmo, 21153, Sweden

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

pomaglumetad methionilLY 2140023

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 7, 2011

Study Start

December 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 21, 2013

Record last verified: 2012-11

Locations

SE(2)GR(1)FR(1)PL(2)AU(1)PR(1)RO(1)DE(2)ES(2)US(36)BR(2)