Trial Outcomes & Findings for A mGlu2/3 Agonist in the Treatment of PTSD (NCT NCT02234687)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2018-11-02

Participant Flow

No Outcome Measures Analyzed; Study Terminated

Participant milestones

Participant milestones
Measure	40 mg Poma Study Terminated. No outcome measures were analyzed	Placebo Study Terminated. No outcome measures were analyzed	160 mg Poma Study Terminated. No outcome measures were analyzed
Overall Study STARTED	6	4	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A mGlu2/3 Agonist in the Treatment of PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants	40 mg Poma n=4 Participants	160 mg Poma n=4 Participants	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pomaglumetad Methionil 160mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pomaglumetad Methionil 40mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=6 participants at risk Placebo, one dose Placebo: Placebo, one dose, one time	Pomaglumetad Methionil 160mg n=4 participants at risk Pomaglumetad Methionil 160mg, one dose, one time	Pomaglumetad Methionil 40mg n=4 participants at risk Pomaglumetad Methionil 40mg, one dose, one time
Gastrointestinal disorders Vomiting after receiving medication	0.00% 0/6 • 6 Months	0.00% 0/4 • 6 Months	50.0% 2/4 • Number of events 2 • 6 Months
General disorders PTSD symptoms became worse after the study	16.7% 1/6 • Number of events 1 • 6 Months	0.00% 0/4 • 6 Months	0.00% 0/4 • 6 Months

Additional Information

Charles Marmar, MD

New York University School of Medicine

Phone: 646 754 4855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place