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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH112800-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.
A double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with POMA (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using MRI techniques. The GO NO-GO decision will be whether or not any dose tested in the R61 phase of the trial decreases left hippocampal CA1 region cerebral blood volume (CBV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POMA 40mg BID (80mg) | Experimental | Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days. |
|
| POMA 80mg BID (160 mg) | Experimental | Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days |
|
| POMA 120mg BID (240mg) | Experimental | Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days |
|
| POMA 160 mg BID (320 mg) | Experimental | Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomaglumetad methionil | Drug | metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14 | Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2) | Baseline to 14 days of POMA/placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Small, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
participants who were randomized (received at least one dose of POMA).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | POMA 80mg BID (160 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14 | Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2) | participants who completed both baseline and Day 14 scans | Posted | Mean | Standard Deviation | Percent change | Baseline to 14 days of POMA/placebo |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ragy Girgis, MD | New York State Psychiatric Institute | 646-774-5553 | ragy.girgis@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2020 | Sep 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2021 | Sep 2, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2020 | Oct 5, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C000626254 | pomaglumetad methionil |
| C437187 | poly(n-octyl methacrylate) |
| C534551 | LY 2140023 |
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Double-blind, randomized, phase 1b, multiple dose trial
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Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
|
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
Pomaglumetad methionil: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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 | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | 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 | 0 | 3 | 0 | 3 | 2 | 3 |
| lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| itching/restlessness | General disorders | Non-systematic Assessment |
|
| sedation | Nervous system disorders | Non-systematic Assessment |
|
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