Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202.
Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202 in an open label extension trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
Office of Psychiatric Research
Birmingham, Alabama, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Chicago Research Center
Chicago, Illinois, United States
The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
Time frame: 48 Months
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University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, United States
PharmaSite Research, Inc.
Baltimore, Maryland, United States
Boston Clinical Trials Inc.
Roslindale, Massachusetts, United States
Woodlands Professional Princeton Medical Institute Building
Princeton, New Jersey, United States
Finger Lake Clinical Research
Rochester, New York, United States
Lindner Center of HOPE
Mason, Ohio, United States
PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic
Salt Lake City, Utah, United States