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Trial record 1 of 1 for:    NCT01487083
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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

November 30, 2011
December 7, 2011
January 21, 2013
December 2011
October 2012   (Final data collection date for primary outcome measure)
  • Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 5 years ]
  • Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 5 years ]
  • Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 5 years ]
  • Proportion of participants with clinically significant weight change from baseline up to 5 years [ Time Frame: Baseline up to 5 years ]
  • Categorical change from baseline up to 5 years in prolactin level [ Time Frame: Baseline, up to 5 years ]
  • Categorical change from baseline up to 5 years in fasting glucose and lipids [ Time Frame: Baseline, up to 5 years ]
Same as current
Complete list of historical versions of study NCT01487083 on ClinicalTrials.gov Archive Site
  • Time to lack of efficacy [ Time Frame: Baseline up to 5 years ]
  • Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline up to 5 years ]
  • Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline, up to 5 years ]
  • Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS) [ Time Frame: Baseline, up to 5 years ]
Same as current
Not Provided
Not Provided
 
A Long-Term Study in Schizophrenia
Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia
The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: Pomaglumetad methionil
Administered orally
Other Name: LY2140023
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.
Intervention: Drug: Pomaglumetad methionil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
282
Same as current
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Brazil,   France,   Germany,   Greece,   Poland,   Puerto Rico,   Romania,   Spain,   Sweden,   United States
Belgium
 
NCT01487083
12666
H8Y-MC-HBBV ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP