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Open Label Extension for GLYX13-C-202, NCT01684163

NCT02192099 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-11-27

Study results available
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Summary

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

Conditions

Interventions

DRUG

Rapastinel (225 mg/450 mg IV administration)

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

Sponsors & Collaborators

  • Naurex, Inc, an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Jenna Hoogerheyde · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-08
Primary Completion
2018-11-08
Completion
2018-11-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02192099 on ClinicalTrials.gov