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

May 16, 2022 updated by: Aptinyx

A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Aptinyx Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Aptinyx Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 30322
        • Aptinyx Clinical Site
    • California
      • Bellflower, California, United States, 90706
        • Aptinyx Clinical Site
      • Glendale, California, United States, 91206
        • Aptinyx Clinical Site
      • Imperial, California, United States, 92251
        • Aptinyx Clinical Site
      • Oakland, California, United States, 94607
        • Aptinyx Clinical Site
      • Oceanside, California, United States, 92056
        • Aptinyx Clinical Site
      • Orange, California, United States, 92868
        • Aptinyx Clinical Site
      • Riverside, California, United States, 92503
        • Aptinyx Clinical Site
      • San Diego, California, United States, 92103
        • Aptinyx Clinical Site
      • San Marcos, California, United States, 92078
        • Aptinyx Clinical Site
      • Santa Ana, California, United States, 92705
        • Aptinyx Clinical Site
      • Temecula, California, United States, 32591
        • Aptinyx Clinical Site
      • Torrance, California, United States, 90502
        • Aptinyx Clinical Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Aptinyx Clinical Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Aptinyx Clinical Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Aptinyx Clinical Site
      • Lauderhill, Florida, United States, 33319
        • Aptinyx Clinical Site
      • Orlando, Florida, United States, 32801
        • Aptinyx Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Aptinyx
      • Atlanta, Georgia, United States, 30331
        • Aptinyx Clinical Site
    • Illinois
      • Hoffman Estates, Illinois, United States, 60619
        • Aptinyx Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Aptinyx Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Aptinyx Clinical Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Aptinyx Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Aptinyx Clinical Site
      • New York, New York, United States, 10036
        • Aptinyx Clinical Site
      • Staten Island, New York, United States, 10312
        • Aptinyx Clinical Site
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Aptinyx Clinical Site
    • Ohio
      • Canton, Ohio, United States, 44720
        • Aptinyx Clinical Site
      • Cincinnati, Ohio, United States, 45219
        • Aptinyx Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73107
        • Aptinyx Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Aptinyx Clinical Site
    • Texas
      • Austin, Texas, United States, 78737
        • Aptinyx Clinical Site
      • San Antonio, Texas, United States, 78229
        • Aptinyx Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Aptinyx Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: 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.
Change from baseline to week 4 (Stage 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PCL-5 (PTSD-Checklist for DSM-5)
Time Frame: 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.
Change from baseline to week 4 (Stage 1)
PSQI (Pittsburgh Sleep Quality Index) Global Score
Time Frame: 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.
Change from baseline to week 4 (Stage 1)
PSQI-A (Pittsburgh Sleep Quality Index-Addendum) Global Score
Time Frame: 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.
Change from baseline to week 4 (Stage 1)
BAC (Brief Assessment of Cognition) Symbol Coding
Time Frame: 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.
Change from baseline to week 4 (Stage 1)
CGI-S (Clinical Global Impression - Severity)
Time Frame: 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).
Change from baseline to week 4 (Stage 1)
HADS-A (Hospital Anxiety and Depression Scale)
Time Frame: 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.
From baseline to week 4 (Stage 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aptinyx

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
Premier Research Group plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYX-783-2004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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