Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

• Sponsor: Aptinyx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04044664
• Collaborator: Premier Research Group plc (Industry), Massachusetts General Hospital (Other)
• Enrollment: 160
• Locations: 37
• Arms: 3
• Actual Duration (Months): 18.3
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic Stress Disorder population.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Drug: Placebo oral capsule; Drug: NYX-783	Phase 2

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized to receive placebo or NYX-783.Subjects will be randomized to receive placebo or NYX-783.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
• Actual Study Start Date: Jan 25, 2019
• Actual Primary Completion Date: Aug 5, 2020
• Actual Study Completion Date: Aug 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo oral capsule; Matching placebo capsules.
Experimental: NYX-783 Low Dose (10 mg QD)	Drug: NYX-783; NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Experimental: NYX-783 High Dose (50 mg QD)	Drug: NYX-783; NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

Outcome Measures

Primary Outcome Measures

1. CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores [Change from baseline to week 4 (Stage 1)]

   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.

Secondary Outcome Measures

1. PCL-5 (PTSD-Checklist for DSM-5) [Change from baseline to week 4 (Stage 1)]

   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.

2. PSQI (Pittsburgh Sleep Quality Index) Global Score [Change from baseline to week 4 (Stage 1)]

   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.

3. PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score [Change from baseline to week 4 (Stage 1)]

   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.

4. BAC (Brief Assessment of Cognition) Symbol Coding [Change from baseline to week 4 (Stage 1)]

   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.

5. CGI-S (Clinical Global Impression - Severity) [Change from baseline to week 4 (Stage 1)]

   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).

6. HADS-A (Hospital Anxiety and Depression Scale) [From baseline to week 4 (Stage 1)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic event occurring ≥12 months prior to screening.

• PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.

• CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

Exclusion Criteria:

• Complex PTSD.

• Trauma focused psychotherapies.

• Primary traumatic event occurred prior to 2001.

• Primary traumatic event was followed by further major traumatic life episodes.

• Other psychiatric disorders that is the primary focus of treatment or followed/worsened since exposure to the trauma (except for major depressive disorder or anxiety disorders that followed exposure to the trauma or an anxiety disorder that showed a worsening after trauma)

• Current use of medications with primarily central nervous system activities

• Other clinically significant medical histories that may interfere with completing the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aptinyx Clinical Site	Tuscaloosa	Alabama	United States	35404
2	Aptinyx Clinical Site	Phoenix	Arizona	United States	85012
3	Aptinyx Clinical Site	Little Rock	Arkansas	United States	30322
4	Aptinyx Clinical Site	Bellflower	California	United States	90706
5	Aptinyx Clinical Site	Glendale	California	United States	91206
6	Aptinyx Clinical Site	Imperial	California	United States	92251
7	Aptinyx Clinical Site	Oakland	California	United States	94607
8	Aptinyx Clinical Site	Oceanside	California	United States	92056
9	Aptinyx Clinical Site	Orange	California	United States	92868
10	Aptinyx Clinical Site	Riverside	California	United States	92503
11	Aptinyx Clinical Site	San Diego	California	United States	92103
12	Aptinyx Clinical Site	San Marcos	California	United States	92078
13	Aptinyx Clinical Site	Santa Ana	California	United States	92705
14	Aptinyx Clinical Site	Temecula	California	United States	32591
15	Aptinyx Clinical Site	Torrance	California	United States	90502
16	Aptinyx Clinical Site	Colorado Springs	Colorado	United States	80910
17	Aptinyx Clinical Site	Norwich	Connecticut	United States	06360
18	Aptinyx Clinical Site	Jacksonville	Florida	United States	32256
19	Aptinyx Clinical Site	Lauderhill	Florida	United States	33319
20	Aptinyx Clinical Site	Orlando	Florida	United States	32801
21	Aptinyx	Atlanta	Georgia	United States	30329
22	Aptinyx Clinical Site	Atlanta	Georgia	United States	30331
23	Aptinyx Clinical Site	Hoffman Estates	Illinois	United States	60619
24	Aptinyx Clinical Site	Boston	Massachusetts	United States	02131
25	Aptinyx Clinical Site	Las Vegas	Nevada	United States	89102
26	Aptinyx Clinical Site	Berlin	New Jersey	United States	08009
27	Aptinyx Clinical Site	Cedarhurst	New York	United States	11516
28	Aptinyx Clinical Site	New York	New York	United States	10036
29	Aptinyx Clinical Site	Staten Island	New York	United States	10312
30	Aptinyx Clinical Site	Salisbury	North Carolina	United States	28144
31	Aptinyx Clinical Site	Canton	Ohio	United States	44720
32	Aptinyx Clinical Site	Cincinnati	Ohio	United States	45219
33	Aptinyx Clinical Site	Oklahoma City	Oklahoma	United States	73107
34	Aptinyx Clinical Site	Memphis	Tennessee	United States	38119
35	Aptinyx Clinical Site	Austin	Texas	United States	78737
36	Aptinyx Clinical Site	San Antonio	Texas	United States	78229
37	Aptinyx Clinical Site	Bellevue	Washington	United States	98007

Sponsors and Collaborators

• Aptinyx
• Premier Research Group plc
• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - May 1, 2020
• Statistical Analysis Plan - Sep 18, 2020

More Information

Publications

None provided.

• Responsible Party: Aptinyx
• ClinicalTrials.gov Identifier: NCT04044664
• Other Study ID Numbers: NYX-783-2004
• First Posted: Aug 5, 2019
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Period Title: Stage 1
STARTED	103	26	23
COMPLETED	86	19	20
NOT COMPLETED	17	7	3
Period Title: Stage 1
STARTED	76	26	22
From Placebo, Responder	20	13	11
From Placebo, Non-Responder	18	13	11
From NYX-783 (10 mg or 50 mg)	38	0	0
COMPLETED	67	24	21
NOT COMPLETED	9	2	1

Baseline Characteristics

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)	Total
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	Total of all reporting groups
Overall Participants	103	26	23	152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.8 (11.42)	43.8 (12.54)	43.7 (11.96)	41.8 (11.7)
Sex: Female, Male (Count of Participants)
Female	61 59.2%	15 57.7%	16 69.6%	92 60.5%
Male	42 40.8%	11 42.3%	7 30.4%	60 39.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 7.7%	0 0%	2 1.3%
Asian	4 3.9%	0 0%	2 8.7%	6 3.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	23 22.3%	6 23.1%	6 26.1%	35 23%
White	75 72.8%	17 65.4%	15 65.2%	107 70.4%
More than one race	1 1%	1 3.8%	0 0%	2 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	103 100%	26 100%	23 100%	152 100%
Baseline CAPS-5 Total Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	40.6 (7.58)	36.5 (7.37)	38.3 (8.26)	39.6 (7.76)

Outcome Measures

1. Primary Outcome

Title	CAPS-5 [Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)] Total Score and Subscores
Description	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.
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
CAPS-5 Total Score	-13.4 (1.06)	-15.7 (2.24)	-11.6 (2.19)
Intrusion sub-score	-4.4 (0.35)	-4.3 (0.75)	-3.7 (0.72)
Avoidance sub-score	-1.8 (0.21)	-2.2 (0.44)	-1.4 (0.44)
Cognition and Mood sub-score	-4.2 (0.5)	-5.7 (1.05)	-3.4 (1.04)
Arousal and Reactivity sub-score	-2.7 (.28)	-4.1 (0.61)	-3.5 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments	CAPS-5 Total Score
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1728
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments	Cognition and Mood sub-score
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0962
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments	Arousal and Reactivity sub-score
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0191
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	PCL-5 (PTSD-Checklist for DSM-5)
Description	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.
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
Mean (Standard Deviation) [units on a scale]	-16.6 (14.75)	-19.9 (13.58)	-17.0 (16.45)

3. Secondary Outcome

Title	PSQI (Pittsburgh Sleep Quality Index) Global Score
Description	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.
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
Mean (Standard Deviation) [units on a scale]	-1.5 (3.37)	-1.2 (2.89)	-1.8 (4.04)

4. Secondary Outcome

Title	PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
Description	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.
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	86	19	20
Mean (Standard Deviation) [units on a scale]	-2.9 (3.76)	-1.9 (2.66)	-3.1 (4.84)

5. Secondary Outcome

Title	BAC (Brief Assessment of Cognition) Symbol Coding
Description	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.
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
Mean (Standard Deviation) [units on a scale]	3.8 (8.07)	2.9 (9.00)	1.3 (5.37)

6. Secondary Outcome

Title	CGI-S (Clinical Global Impression - Severity)
Description	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).
Time Frame	Change from baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
Mean (Standard Deviation) [units on a scale]	-1.1 (1.09)	-1.2 (1.03)	-1.3 (0.99)

7. Secondary Outcome

Title	HADS-A (Hospital Anxiety and Depression Scale)
Description	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.
Time Frame	From baseline to week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, all randomized subjects

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
Mean (Standard Error) [units on a scale]	-3.0 (.34)	-4.4 (0.72)	-4.2 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0452
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 Low Dose (10 mg QD)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0614
	Comments
	Method	t-test, 1 sided
	Comments

8. Post-Hoc Outcome

Title	Responders (30% and 50% Improvement From Baseline) in CAPS-5 Total Score
Description	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.
Time Frame	Baseline to Week 4 (Stage 1)

Outcome Measure Data

Analysis Population Description

Intent to Treat, subjects who completed Week 4

Arm/Group Title	Placebo	NYX-783 High Dose (50 mg QD)	NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).	NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Measure Participants	103	26	23
30% decrease from baseline	38 36.9%	14 53.8%	9 39.1%
50% decrease from baseline	23 22.3%	9 34.6%	6 26.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments	greater than or equal to 30% decrease from baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0182
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, NYX-783 High Dose (50 mg QD)
	Comments	greater than or equal to 50% decrease from baseline
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0705
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	Stage 1: 4 weeks, Stage 2: 4 weeks
Adverse Event Reporting Description	Adverse Events were assessed at protocol specified study visits.
Arm/Group Title	Placebo		NYX-783 High Dose (50 mg QD)		NYX-783 Low Dose (10 mg QD)
Arm/Group Description	Placebo oral capsule: Matching placebo capsules.		NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).		NYX-783: NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
All Cause Mortality
	Placebo		NYX-783 High Dose (50 mg QD)		NYX-783 Low Dose (10 mg QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/52 (0%)		0/46 (0%)
Serious Adverse Events
	Placebo		NYX-783 High Dose (50 mg QD)		NYX-783 Low Dose (10 mg QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/52 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		NYX-783 High Dose (50 mg QD)		NYX-783 Low Dose (10 mg QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/141 (6.4%)		4/52 (7.7%)		3/46 (6.5%)
Infections and infestations
Urinary Tract Infection	1/141 (0.7%)	1	2/52 (3.8%)	2	0/46 (0%)	0
Nervous system disorders
Headache	8/141 (5.7%)	8	2/52 (3.8%)	2	3/46 (6.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.