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Trial record 16 of 24 for:    LY2140023

A mGlu2/3 Agonist in the Treatment of PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234687
Recruitment Status : Terminated (The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.)
First Posted : September 9, 2014
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Post-traumatic Stress Disorder
Interventions Drug: Pomaglumetad Methionil 160mg
Drug: Pomaglumetad Methionil 40mg
Drug: Placebo
Enrollment 10
Recruitment Details No Outcome Measures Analyzed; Study Terminated
Pre-assignment Details No Outcome Measures Analyzed; Study Terminated
Arm/Group Title 40 mg Poma Placebo 160 mg Poma
Hide Arm/Group Description Study Terminated. No outcome measures were analyzed Study Terminated. No outcome measures were analyzed Study Terminated. No outcome measures were analyzed
Period Title: Overall Study
Started 6 [1] 4 4
Completed 0 [1] 0 0
Not Completed 6 4 4
[1]
Study Terminated. No outcome measures were analyzed
Arm/Group Title Placebo 40 mg Poma 160 mg Poma Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 4 4 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 4 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
4
 100.0%
4
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 4 participants 14 participants
Female
3
  50.0%
2
  50.0%
2
  50.0%
7
  50.0%
Male
3
  50.0%
2
  50.0%
2
  50.0%
7
  50.0%
1.Primary Outcome
Title To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients were enrolled and data for these 10 patients was not analyzed. Assuming a 2-tailed test,power=0.80, alpha=0.05, a total sample size of 30 (10 per group) is required to detect a moderate differential effect size change of a 160mg or 40 mg dose of pomaglumated methionil relative to placebo.
Arm/Group Title Placebo Pomaglumetad Methionil 160mg Pomaglumetad Methionil 40mg
Hide Arm/Group Description:
Placebo: Placebo, one dose, one time
Pomaglumetad Methionil 160mg, one dose, one time Pomaglumetad Methionil 160mg: Pomaglumetad Methionil 160mg, one dose, one time
Pomaglumetad Methionil 40mg, one dose, one time Pomaglumetad Methionil 40mg: Pomaglumetad Methionil 40mg, one dose, one time
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pomaglumetad Methionil 160mg Pomaglumetad Methionil 40mg
Hide Arm/Group Description Placebo, one dose Placebo: Placebo, one dose, one time Pomaglumetad Methionil 160mg, one dose, one time Pomaglumetad Methionil 40mg, one dose, one time
All-Cause Mortality
Placebo Pomaglumetad Methionil 160mg Pomaglumetad Methionil 40mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pomaglumetad Methionil 160mg Pomaglumetad Methionil 40mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Pomaglumetad Methionil 160mg Pomaglumetad Methionil 40mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/4 (0.00%)      2/4 (50.00%)    
Gastrointestinal disorders       
Vomiting after receiving medication   0/6 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2
General disorders       
PTSD symptoms became worse after the study   1/6 (16.67%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
10 patients were enrolled and data for these 10 patients was not analyzed because enrollment must reach a certain threshold for reporting.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Charles Marmar, MD
Organization: New York University School of Medicine
Phone: 646 754 4855
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02234687     History of Changes
Other Study ID Numbers: 13-00609
First Submitted: September 3, 2014
First Posted: September 9, 2014
Results First Submitted: May 4, 2016
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018