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TERMINATED

NCT01487083

PHASE3

A Long-Term Safety Study of Pomaglumetad Methionil in Schizophrenia

Sponsor: Denovo Biopharma LLC

View on ClinicalTrials.gov

Summary

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

Official title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2011-12

Completion Date

2012-10

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

Pomaglumetad methionil

Administered orally

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methionil * Have any other current psychiatric diagnoses in addition to schizophrenia * Have previously completed or withdrawn from this study, or any other study investigating pomaglumetad methionil or any predecessor molecules with glutamatergic activity, except for participants who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 milliseconds (msec) (male) or \>470 msec (female) at study entry

Locations (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, United States

Escondido, California, United States

Garden Grove, California, United States

Long Beach, California, United States

San Diego, California, United States

Sherman Oaks, California, United States

Torrance, California, United States

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

Coral Gables, Florida, United States

Lauderhill, Florida, United States

Maitland, Florida, United States

North Miami, Florida, United States

Oakland Park, Florida, United States

Sanford, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lake Charles, Louisiana, United States

Flowood, Mississippi, United States

Creve Coeur, Missouri, United States

Marlton, New Jersey, United States

Princeton, New Jersey, United States

Brooklyn, New York, United States

Cedarhurst, New York, United States

Fresh Meadows, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

Charlotte, North Carolina, United States

Beachwood, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

DeSoto, Texas, United States

Wharton, Texas, United States

Richmond, Virginia, United States

Vienna, Austria

Salvador, Brazil

São Paulo, Brazil

Limoges, France

Dresden, Germany

Oranienburg, Germany

Chaïdári, Greece

Bialystok, Poland

Gdynia, Poland

San Juan, Puerto Rico

Bucharest, Romania

Madrid, Spain

Vic, Spain

Luleå, Sweden

Malmö, Sweden