CClinicalTrials.gg
TerminatedNCT02234687Updated Nov 2, 2018Results posted

A mGlu2/3 Agonist in the Treatment of PTSD

A Phase 1 interventional study of Pomaglumetad Methionil 160mg and Pomaglumetad Methionil 40mg in Post-traumatic Stress Disorder, sponsored by NYU Langone Health. Terminated. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment

Why this study was terminated
The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Post-traumatic Stress Disorder

Keywords

  • post-traumatic stress disorder
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women between 18 and 60 years of age, any race
  • Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
  • Able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia, schizoaffective disorder, bipolar disorder
  • History of moderate or severe traumatic brain injury (TBI) with loss of consciousness
  • Lifetime history of seizure disorder
  • Current diagnosis of obsessive-compulsive disorder (OCD)
  • Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder
  • Alcohol or drug abuse in the past 90 days, or dependence in the past year.
  • Individuals with a cumulative lifetime history of intravenous substance abuse longer than 1 year.
  • Severe dissociation, defined as a Clinician Administered Dissociative States Scale (CADSS) score greater than 60 at baseline
  • Patients with creatinine clearance \<60 milliliters (mL)/min (moderate renal impairment)
  • Current pregnancy or breast feeding; medical conditions that could interfere with correct interpretation of study data, i.e., individuals with the following medical conditions will be excluded: cancer in the past year, stroke, heart attack, angina, neurological disease (multiple sclerosis, epilepsy, Parkinson's disease), central nervous system (CNS) lesions including TBI with loss of consciousness, dementing illness, and/or liver or kidney disease. Patients with QT interval >450 msec (males) and >470 msec (females).
  • Participants who have started new medication regimen for PTSD within 3 months prior to study start and subjects taking fluoxetine
  • Current suicidality defined by emergent Columbia Suicide Severity Rating Scale (CSSRS)-defined suicidal behavior, a suicidal ideation score of 5 (indicating active suicidal ideation with specific plan and some level of intent) or 4 (indicating active suicidal ideation with some intent to act, without specific plan) on the CSSRS or in the absence of a CSSRS suicidal ideation score of 5 or 4 or CSSRS-defined suicidal behavior, if the investigator determines the patient to have a significant short-term risk for a suicide attempt.
  • Individuals with active suicidal risk, active self-mutilation or aggressive behavior with threatening behavior toward others within the past year, as judged by the Principal Investigator
  • Pregnant or lactating women
  • Legal and Financial: Current legal proceedings resulting from the traumatic events. People whose continued receipt of financial benefits is contingent upon maintaining PTSD symptoms or who are waiting for a decision concerning the receipt of financial benefits based upon PTSD symptoms
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo, one dose

    Drug: Placebo

  • Experimental
    Pomaglumetad Methionil 40mg

    Pomaglumetad Methionil 40mg, one dose, one time

    Drug: Pomaglumetad Methionil 40mg

  • Experimental
    Pomaglumetad Methionil 160mg

    Pomaglumetad Methionil 160mg, one dose, one time

    Drug: Pomaglumetad Methionil 160mg

Interventions

  • DrugPomaglumetad Methionil 160mg

    Pomaglumetad Methionil 160mg, one dose, one time

    Also known as: LY2140023

  • DrugPomaglumetad Methionil 40mg

    Pomaglumetad Methionil 40mg, one dose, one time

    Also known as: LY2140023

  • DrugPlacebo

    Placebo, one dose, one time

06

What researchers measure

Primary outcomes

  1. To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil

    To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.

    Time frame: 6 months

07

Results

Posted Nov 2, 2018
Limitations and caveats
10 patients were enrolled and data for these 10 patients was not analyzed because enrollment must reach a certain threshold for reporting.

Participant flow

No Outcome Measures Analyzed; Study Terminated

Participant flow — Overall Study
Milestone40 mg PomaPlacebo160 mg Poma
Started644
Completed000
Not completed644

Outcome measures

PrimaryTo Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil

To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.

Time frame:
6 months

No measurements were reported for this outcome.

Adverse events

Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/6 (0%)0/6 (0%)1/6 (16.7%)
Pomaglumetad Methionil 160mg0/4 (0%)0/4 (0%)0/4 (0%)
Pomaglumetad Methionil 40mg0/4 (0%)0/4 (0%)2/4 (50%)
Most frequent other events
Most frequent other events
EventPlaceboPomaglumetad Methionil 160mgPomaglumetad Methionil 40mg
Vomiting after receiving medicationGastrointestinal disorders0/60/42/4
PTSD symptoms became worse after the studyGeneral disorders1/60/40/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo40 mg Poma160 mg PomaTotal
<=18 years0000
Between 18 and 65 years64414
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Placebo40 mg Poma160 mg PomaTotal
Female3227
Male3227
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02234687
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Sep 9, 2014
Start date
Sep 2014
Primary completion
Feb 11, 2016
Completion
Sep 11, 2016
Results posted
Nov 2, 2018
Last update
Nov 2, 2018

Study contacts

Charles Marmar, MD
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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