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| Name | Class |
|---|---|
| Premier Research | OTHER |
| Massachusetts General Hospital | OTHER |
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To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.
The study will be a 10 to 12-week study, including a 1 to 3-week screening Period, followed by a double-blind, randomized, placebo-controlled, parallel-group Treatment Period, and a 1-week follow-up Period. Subjects eligible for the study will be randomized to receive either NYX-783 (4-weeks) or placebo (4 or 8-weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| NYX-783 Low Dose (10 mg QD) | Experimental |
| |
| NYX-783 High Dose (50 mg QD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | Matching placebo capsules. |
| |
| NYX-783 |
| Measure | Description | Time Frame |
|---|---|---|
| CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores | CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD. | Change from baseline to week 4 (Stage 1) |
| Measure | Description | Time Frame |
|---|---|---|
| PCL-5 (PTSD-Checklist for DSM-5) | Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5. The PCL-5 ranges from 0 to 80; a higher score corresponds to more severe PTSD. | Change from baseline to week 4 (Stage 1) |
| PSQI (Pittsburgh Sleep Quality Index) Global Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aptinyx Clinical Site | Tuscaloosa | Alabama | 35404 | United States | ||
| Aptinyx Clinical Site |
Participants were randomized to Placebo, NYX-783 50mg QD, or NYX-783 10mg QD during Stage 1. Participants were re-randomized to Placebo, NYX-783 50mg QD, or NYX-783 10mg QD in Stage 2. Participants who received Placebo in Stage 1 were classified as Responders or Non-responders in Stage 2.
160 subjects were randomized. 7 subjects received 50mg QW in a prior protocol version; they were not assigned to the Arms/Groups above. 1 subject was randomized in Stage 1 but did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo oral capsule: Matching placebo capsules. |
| FG001 | NYX-783 High Dose (50 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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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 | May 1, 2020 | Nov 30, 2021 |
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Subjects will be randomized to receive placebo or NYX-783.
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| Drug |
NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
|
Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score. The PSQI is a questionnaire to assess sleep quality and disturbances. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score >5 indicates significant sleep disturbance. |
| Change from baseline to week 4 (Stage 1) |
| PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score | Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score. The PSQI-A score ranges from 0-21; lower scores represent less disruptive behavior. | Change from baseline to week 4 (Stage 1) |
| BAC (Brief Assessment of Cognition) Symbol Coding | Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding. BAC symbol coding score is a count which ranges from 0 to 110; higher scores represent higher function. | Change from baseline to week 4 (Stage 1) |
| CGI-S (Clinical Global Impression - Severity) | Assess the effect of NYX-783 compared to placebo in the change in global clinical severity of PTSD symptoms as measured by the CGI-S. The Clinical Global Impressions-Severity (CGI-S) score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). | Change from baseline to week 4 (Stage 1) |
| HADS-A (Hospital Anxiety and Depression Scale) | The HADS is a self-assessment tool consisting of two subscales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a Depression score (HADS-D), or can be added to produce a total score (HADS-T). Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-42 and sub scores for anxiety or depression ranging from 0-21 for each subscale. Higher scores represent more severe anxiety or depression. HADS-A is presented here. | From baseline to week 4 (Stage 1) |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Aptinyx Clinical Site | Little Rock | Arkansas | 30322 | United States |
| Aptinyx Clinical Site | Bellflower | California | 90706 | United States |
| Aptinyx Clinical Site | Glendale | California | 91206 | United States |
| Aptinyx Clinical Site | Imperial | California | 92251 | United States |
| Aptinyx Clinical Site | Oakland | California | 94607 | United States |
| Aptinyx Clinical Site | Oceanside | California | 92056 | United States |
| Aptinyx Clinical Site | Orange | California | 92868 | United States |
| Aptinyx Clinical Site | Riverside | California | 92503 | United States |
| Aptinyx Clinical Site | San Diego | California | 92103 | United States |
| Aptinyx Clinical Site | San Marcos | California | 92078 | United States |
| Aptinyx Clinical Site | Santa Ana | California | 92705 | United States |
| Aptinyx Clinical Site | Temecula | California | 32591 | United States |
| Aptinyx Clinical Site | Torrance | California | 90502 | United States |
| Aptinyx Clinical Site | Colorado Springs | Colorado | 80910 | United States |
| Aptinyx Clinical Site | Norwich | Connecticut | 06360 | United States |
| Aptinyx Clinical Site | Jacksonville | Florida | 32256 | United States |
| Aptinyx Clinical Site | Lauderhill | Florida | 33319 | United States |
| Aptinyx Clinical Site | Orlando | Florida | 32801 | United States |
| Aptinyx | Atlanta | Georgia | 30329 | United States |
| Aptinyx Clinical Site | Atlanta | Georgia | 30331 | United States |
| Aptinyx Clinical Site | Hoffman Estates | Illinois | 60619 | United States |
| Aptinyx Clinical Site | Boston | Massachusetts | 02131 | United States |
| Aptinyx Clinical Site | Las Vegas | Nevada | 89102 | United States |
| Aptinyx Clinical Site | Berlin | New Jersey | 08009 | United States |
| Aptinyx Clinical Site | Cedarhurst | New York | 11516 | United States |
| Aptinyx Clinical Site | New York | New York | 10036 | United States |
| Aptinyx Clinical Site | Staten Island | New York | 10312 | United States |
| Aptinyx Clinical Site | Salisbury | North Carolina | 28144 | United States |
| Aptinyx Clinical Site | Canton | Ohio | 44720 | United States |
| Aptinyx Clinical Site | Cincinnati | Ohio | 45219 | United States |
| Aptinyx Clinical Site | Oklahoma City | Oklahoma | 73107 | United States |
| Aptinyx Clinical Site | Memphis | Tennessee | 38119 | United States |
| Aptinyx Clinical Site | Austin | Texas | 78737 | United States |
| Aptinyx Clinical Site | San Antonio | Texas | 78229 | United States |
| Aptinyx Clinical Site | Bellevue | Washington | 98007 | United States |
| FG002 | NYX-783 Low Dose (10 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Stage 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oral capsule: Matching placebo capsules. |
| BG001 | NYX-783 High Dose (50 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
| BG002 | NYX-783 Low Dose (10 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline CAPS-5 Total Score | CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (minimum score 0, maximum score 80). A higher score corresponds to more severe PTSD. | Mean | Standard Deviation | units on a scale |
|
| 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 | CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores | CAPS-5 [Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] is a structured interview for diagnosis and assessment of PTSD. The assessor combines information about frequency and intensity of an item into a severity rating (0-4). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: intrusions (items 1-5, minimum score 0, maximum score 20), avoidance (items 6-7, minimum score 0, maximum score 8), negative alterations in cognitions and mood (items 8-14, minimum score 0, maximum score 28), and alterations in arousal and reactivity (items 15-20, minimum score 0, maximum score 24). CAPS-5 Total Scores range from 0 to 80. A higher score corresponds to more severe PTSD. | Intent to Treat, all randomized subjects | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline to week 4 (Stage 1) |
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| Secondary | PCL-5 (PTSD-Checklist for DSM-5) | Assess the effect of NYX-783 compared to placebo in changes of symptoms as measured by PCL-5. The PCL-5 ranges from 0 to 80; a higher score corresponds to more severe PTSD. | Intent to Treat, all randomized subjects | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (Stage 1) |
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| Secondary | PSQI (Pittsburgh Sleep Quality Index) Global Score | Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI Global Score. The PSQI is a questionnaire to assess sleep quality and disturbances. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A score >5 indicates significant sleep disturbance. | Intent to Treat, all randomized subjects | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (Stage 1) |
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| Secondary | PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score | Assess the effects of NYX-783 compared to placebo in changes in sleep quality as measure by the PSQI-A Global Score. The PSQI-A score ranges from 0-21; lower scores represent less disruptive behavior. | Intent to Treat, all randomized subjects | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (Stage 1) |
|
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| Secondary | BAC (Brief Assessment of Cognition) Symbol Coding | Assess the effect of NYX-783 compared to placebo in changes in cognitive function as measured by the BAC Symbol Coding. BAC symbol coding score is a count which ranges from 0 to 110; higher scores represent higher function. | Intent to Treat, all randomized subjects | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (Stage 1) |
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| Secondary | CGI-S (Clinical Global Impression - Severity) | Assess the effect of NYX-783 compared to placebo in the change in global clinical severity of PTSD symptoms as measured by the CGI-S. The Clinical Global Impressions-Severity (CGI-S) score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). | Intent to Treat, all randomized subjects | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (Stage 1) |
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| Secondary | HADS-A (Hospital Anxiety and Depression Scale) | The HADS is a self-assessment tool consisting of two subscales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a Depression score (HADS-D), or can be added to produce a total score (HADS-T). Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-42 and sub scores for anxiety or depression ranging from 0-21 for each subscale. Higher scores represent more severe anxiety or depression. HADS-A is presented here. | Intent to Treat, all randomized subjects | Posted | Mean | Standard Error | units on a scale | From baseline to week 4 (Stage 1) |
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| Post-Hoc | Responders (30% and 50% Improvement From Baseline) in CAPS-5 Total Score | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview for diagnosis and assessment of PTSD. A higher score corresponds to more severe PTSD. | Intent to Treat, subjects who completed Week 4 | Posted | Number | participants | Baseline to Week 4 (Stage 1) |
|
|
Stage 1: 4 weeks, Stage 2: 4 weeks
Adverse Events were assessed at protocol specified study visits.
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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 | Placebo | Placebo oral capsule: Matching placebo capsules. | 0 | 141 | 0 | 141 | 9 | 141 |
| EG001 | NYX-783 High Dose (50 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). | 0 | 52 | 0 | 52 | 4 | 52 |
| EG002 | NYX-783 Low Dose (10 mg QD) | NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR). | 0 | 46 | 0 | 46 | 3 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aptinyx Clinical Development | Aptinyx | 847-871-0377 | 1 | clinicalstudies@aptinyx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2020 | Nov 19, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Withdrawal by Subject |
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| protocol deviation |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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|
| Avoidance sub-score |
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| Cognition and Mood sub-score |
|
| Arousal and Reactivity sub-score |
|
| 0.0962 |
| Other |
| Arousal and Reactivity sub-score | t-test, 1 sided | 0.0191 | Other |
|
| Units | Counts |
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| Units | Counts |
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| Participants |
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