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A mGlu2/3 Agonist in the Treatment of PTSD

NCT02234687 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-02

Study results available
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Summary

In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in adults with post-traumatic stress disorder (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg vs placebo in a 1:1:1 ratio).

Conditions

  • Post-traumatic Stress Disorder

Interventions

DRUG

Pomaglumetad Methionil 160mg

Pomaglumetad Methionil 160mg, one dose, one time

DRUG

Pomaglumetad Methionil 40mg

Pomaglumetad Methionil 40mg, one dose, one time

DRUG

Placebo

Placebo, one dose, one time

Sponsors & Collaborators

Principal Investigators

  • Charles Marmar, MD · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-02-11
Completion
2016-09-11
FDA Drug
Yes

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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 NCT02234687 on ClinicalTrials.gov