A mGlu2/3 Agonist in the Treatment of PTSD

NCT02234687 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 13-00609
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

post-traumatic stress disorder

Outcome Measures

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.

  6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo, one dose

Drug: Placebo

Pomaglumetad Methionil 40mg

EXPERIMENTAL

Pomaglumetad Methionil 40mg, one dose, one time

Drug: Pomaglumetad Methionil 40mg

Pomaglumetad Methionil 160mg

EXPERIMENTAL

Pomaglumetad Methionil 160mg, one dose, one time

Drug: Pomaglumetad Methionil 160mg

Interventions

Pomaglumetad Methionil 160mg DRUG

Pomaglumetad Methionil 160mg, one dose, one time

Also known as: LY2140023

Pomaglumetad Methionil 160mg

Pomaglumetad Methionil 40mg DRUG

Pomaglumetad Methionil 40mg, one dose, one time

Also known as: LY2140023

Pomaglumetad Methionil 40mg

Placebo DRUG

Placebo, one dose, one time

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

pomaglumetad methionil; LY 2140023

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

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.

Results Point of Contact

• Title: Charles Marmar, MD
• Organization: New York University School of Medicine

Charles.Marmar@nyumc.org

646 754 4855

Study Officials

• Charles Marmar, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: February 11, 2016
• Study Completion: September 11, 2016
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-03