Trial Outcomes & Findings for Glutamate Reducing Interventions in Schizophrenia (NCT NCT03321617)
NCT ID: NCT03321617
Last Updated: 2021-12-01
Results Overview
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Baseline to 14 days of POMA/placebo
Results posted on
2021-12-01
Participant Flow
5 participants consented to the protocol and underwent screening procedures but were not randomized (did not receive study medication). Reasons for screen fail: 1-withdrew consent 1-unable to undergo scan 3-study was paused due to COVID-19 pandemic
Participant milestones
| Measure |
POMA 40mg BID (80mg)
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 80mg BID (160 mg)
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 120mg BID (240mg)
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 160 mg BID (320 mg)
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamate Reducing Interventions in Schizophrenia
Baseline characteristics by cohort
| Measure |
POMA 40mg BID (80mg)
n=3 Participants
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 80mg BID (160 mg)
n=3 Participants
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 120mg BID (240mg)
n=2 Participants
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 160 mg BID (320 mg)
n=3 Participants
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 days of POMA/placeboPopulation: participants who completed both baseline and Day 14 scans
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
Outcome measures
| Measure |
POMA 40mg BID (80mg)
n=2 Participants
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 80mg BID (160 mg)
n=3 Participants
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 120mg BID (240mg)
n=2 Participants
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 160 mg BID (320 mg)
n=2 Participants
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
|---|---|---|---|---|
|
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
|
0.40684405 Percent change
Standard Deviation .63605395
|
-0.081559 Percent change
Standard Deviation 0.1522939
|
0.0219668 Percent change
Standard Deviation 0.1484273
|
-0.0269017 Percent change
Standard Deviation 0
|
Adverse Events
POMA 40mg BID (80mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
POMA 80mg BID (160 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
POMA 120mg BID (240mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
POMA 160 mg BID (320 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
POMA 40mg BID (80mg)
n=3 participants at risk
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 80mg BID (160 mg)
n=3 participants at risk
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 120mg BID (240mg)
n=2 participants at risk
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
POMA 160 mg BID (320 mg)
n=3 participants at risk
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
66.7%
2/3 • Number of events 2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
50.0%
1/2 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
66.7%
2/3 • Number of events 2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
33.3%
1/3 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
33.3%
1/3 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
|
General disorders
itching/restlessness
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
33.3%
1/3 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
|
Nervous system disorders
sedation
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
33.3%
1/3 • Number of events 1 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/2 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
0.00%
0/3 • From consent to 30 days after last dose of study medication, up to 74 days (30-day screening period, 14-day randomization period, 30 day follow up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place