Open Label Extension for GLYX13-C-202, NCT01684163

NCT02192099 | Terminated Phase 2 Results

• 1 other identifier: GLYX13-C-203
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 10

Brief Summary

Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  48 Months

Study Arms (1)

Rapastinel (225 mg/450 mg IV administration) prefilled syringe

EXPERIMENTAL

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

Drug: Rapastinel (225 mg/450 mg IV administration)

Interventions

Rapastinel (225 mg/450 mg IV administration) DRUG

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

Also known as: GLYX-13 IV Dose

Rapastinel (225 mg/450 mg IV administration) prefilled syringe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have completed 8 weeks of treatment in the preceding study (GLYX13-C-202, NCT01684163.
• Participants who wish to continue treatment with GLYX-13 after the preceding study.
• Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD).
• Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
• Clinical laboratory values \<2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor.
• Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
• Based on the investigator and Naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to major depressive episodes (MDEs) are permitted.

You may not qualify if:

• Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (ADHD), or PTSD.
• A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
• Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis.
• Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes.
• Currently hospitalized or residing in an in-patient facility during study participation.
• Substance abuse since the end of participation in GLYX13-C-202, including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine 4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
• Women who are planning to become pregnant during the course of the study.
• Allergy or intolerance to current antidepressant or other current medications.
• Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial with the exception of GLYX13-C-202.
• Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused
• Pose current (past 6 months) suicide risk based on administration of the C SSRS and the investigator's clinical judgment.
• Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 \& HIV-2 antibody screen) or other ongoing infectious disease.

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc: lead

Study Sites (10)

Office of Psychiatric Research

Birmingham, Alabama, 35294, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

University of Kansas School of Medicine Clinical Trial Unit

Wichita, Kansas, 67214, United States

Location

PharmaSite Research, Inc.

Baltimore, Maryland, 21208, United States

Location

Boston Clinical Trials Inc.

Roslindale, Massachusetts, 02131, United States

Location

Woodlands Professional Princeton Medical Institute Building

Princeton, New Jersey, 08540, United States

Location

Finger Lake Clinical Research

Rochester, New York, 14618, United States

Location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

GLYX-13 peptide; Organization and Administration

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Services Administration

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Jenna Hoogerheyde

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 16, 2014
• Study Start: September 8, 2014
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (10)