A Long-Term Study in Schizophrenia

This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01487083
First received: November 30, 2011
Last updated: January 11, 2013
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Pomaglumetad methionil
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Categorical change from baseline up to 5 years in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: Yes ]
  • Categorical change from baseline up to 5 years in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: Yes ]
  • Categorical change from baseline up to 5 years in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: Yes ]
  • Proportion of participants with clinically significant weight change from baseline up to 5 years [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: Yes ]
  • Categorical change from baseline up to 5 years in prolactin level [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: Yes ]
  • Categorical change from baseline up to 5 years in fasting glucose and lipids [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to lack of efficacy [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: Yes ]
  • Number of participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 5 years in Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: No ]
  • Change from baseline up to 5 years in Brief Psychiatric Rater Scale (BPRS) [ Time Frame: Baseline, up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 282
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487083

  Show 51 Study Locations
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01487083     History of Changes
Other Study ID Numbers: 12666, H8Y-MC-HBBV
Study First Received: November 30, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
Brazil: National Health Surveillance Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Poland: Ethics Committee
Romania: National Medicines Agency
Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014