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
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).
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 →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.
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Exclusion Criteria:
Placebo, one dose
Drug: Placebo
Pomaglumetad Methionil 40mg, one dose, one time
Drug: Pomaglumetad Methionil 40mg
Pomaglumetad Methionil 160mg, one dose, one time
Drug: Pomaglumetad Methionil 160mg
Pomaglumetad Methionil 160mg, one dose, one time
Also known as: LY2140023
Pomaglumetad Methionil 40mg, one dose, one time
Also known as: LY2140023
Placebo, one dose, one time
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
No Outcome Measures Analyzed; Study Terminated
| Milestone | 40 mg Poma | Placebo | 160 mg Poma |
|---|---|---|---|
| Started | 6 | 4 | 4 |
| Completed | 0 | 0 | 0 |
| Not completed | 6 | 4 | 4 |
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.
No measurements were reported for this outcome.
Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Pomaglumetad Methionil 160mg | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Pomaglumetad Methionil 40mg | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Placebo | Pomaglumetad Methionil 160mg | Pomaglumetad Methionil 40mg |
|---|---|---|---|
| Vomiting after receiving medicationGastrointestinal disorders | 0/6 | 0/4 | 2/4 |
| PTSD symptoms became worse after the studyGeneral disorders | 1/6 | 0/4 | 0/4 |
| Age, Categorical(Participants) | Placebo | 40 mg Poma | 160 mg Poma | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 4 | 4 | 14 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | 40 mg Poma | 160 mg Poma | Total |
|---|---|---|---|---|
| Female | 3 | 2 | 2 | 7 |
| Male | 3 | 2 | 2 | 7 |
No study locations are listed for this record.
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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