PTSDPhase 2/3NCT05181995
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
A Phase 2/3 study testing NYX-783 in people with PTSD, run by Aptinyx at 37 sites in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- NYX-783
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 37 sitesUnited States
- Study dates
- 13 Dec 2021to 30 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD (DSM-5 criteria)
- Stable allowed medications with no planned changes from 30 days prior to screening through study participation
- Willing to use highly effective birth control
- Willing to comply with protocol visits and procedures
Who cannot join
- Moderate to severe traumatic brain injury
- Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders
- Substance use disorder or alcohol use disorder within 6 months prior to screening
- Psychotherapy or cognitive based therapy within 30 days prior to screening
- Use of investigational drug within 30 days prior to screening
- Prior participation in study of NYX-783, NYX-2925 or NYX-458.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Aptinyx Clinical Site
Albuquerque, New Mexico, 87102
Aptinyx Clinical Site
Atlanta, Georgia, 30331
Aptinyx Clinical Site
Austin, Texas, 78737
Aptinyx Clinical Site
Bellflower, California, 90706
Aptinyx Clinical Site
Bentonville, Arkansas, 72712
Aptinyx Clinical Site
Boston, Massachusetts, 02131
Aptinyx Clinical Site
Cincinnati, Ohio, 45219
Aptinyx Clinical Site
Colorado Springs, Colorado, 80910
Aptinyx Clinical Site
Dayton, Ohio, 45432
Aptinyx Clinical Site
Denver, Colorado, 80209
Aptinyx Clinical Site
Fort Worth, Texas, 76104
Aptinyx Clinical Site
Glendale, California, 91206
Aptinyx Clinical Site
Hialeah, Florida, 33012
Aptinyx Clinical Site
Hollywood, Florida, 33020
Aptinyx Clinical Site
Houston, Texas, 77090
Aptinyx Clinical Site
Jacksonville, Florida, 32256
Aptinyx Clinical Site
Jupiter, Florida, 33458
Aptinyx Clinical Site
Kettering, Ohio, 45439
Aptinyx Clinical Site
La Jolla, California, 92037
Aptinyx Clinical Site
Las Vegas, Nevada, 89102
Aptinyx Clinical Site
Media, Pennsylvania, 19063
Aptinyx Clinical Site
Memphis, Tennessee, 38119
Aptinyx Clinical Site
Miami, Florida, 33125
Aptinyx Clinical Site
Miami, Florida, 33174
Aptinyx Clinical Site
Miami Lakes, Florida, 33014
Aptinyx Clinical Site
New York, New York, 10036
Aptinyx Clinical Site
North Canton, Ohio, 44720
Aptinyx Clinical Site
Oceanside, California, 92056
Aptinyx Clinical Site
Okeechobee, Florida, 34972
Aptinyx Clinical Site
Orlando, Florida, 32801
Aptinyx Clinical Site
Phoenix, Arizona, 85012
Aptinyx Clinical Site
Plano, Texas, 75093
Aptinyx Clinical Site
Riverside, California, 92506
Aptinyx Clinical Site
Santa Ana, California, 92705
Aptinyx Clinical Site
Temecula, California, 92591
Aptinyx Clinical Site
Torrance, California, 90502
Aptinyx Clinical Site
Tuscaloosa, Alabama, 35404
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)
- Conditions
- PTSD
- Being tested
- NYX-783, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYX-783Drug
NYX-783
PlaceboDrug
Placebo for 50 mg NYX-783
| Study group | Role | What they receive |
|---|---|---|
| 50 mg NYX-783 QD | Experimental | 50 mg NYX-783 QD Receives: Drug: NYX-783 |
| Placebo | Placebo comparator | Placebo QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
Change from Baseline in CAPS-5
Measured: study endpoint, up to 10 weeks
Secondary outcomes (3)
CGI-S (Clinician Global Impression - Severity)
Change from Baseline in CGI-S
Measured: study endpoint, up to 10 weeks
PGI-S (Patient Global Impression - Severity)
Change from Baseline in PGI-S
Measured: study endpoint, up to 10 weeks
SDS (Sheehan Disability Scale)
Change from Baseline in SDS
Measured: study endpoint, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start13 Dec 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptinyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181995
- Sponsor's protocol ID
- NYX-783-2009
- Status last verified
- Apr 2023
- First submitted
- 15 Dec 2021
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT05181995
- Acronym / sponsor ID
- NYX-783-2009
- Conditions
- PTSD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company decision
- Enrolment
- 121 participants (actual)
- Lead sponsor
- AptinyxIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mg NYX-783 QD | Experimental | Drug: NYX-78350 mg NYX-783 QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PTSD (DSM-5 criteria)
- Stable allowed medications with no planned changes from 30 days prior to screening through study participation
- Willing to use highly effective birth control
- Willing to comply with protocol visits and procedures
Key exclusion criteria (6 listed)
- Moderate to severe traumatic brain injury
- Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders
- Substance use disorder or alcohol use disorder within 6 months prior to screening
- Psychotherapy or cognitive based therapy within 30 days prior to screening
- Use of investigational drug within 30 days prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NYX-783NYX-783 | Drug | 50 mg NYX-783 QD |
| PlaceboPlacebo for 50 mg NYX-783 | Drug | Placebo |
Primary outcome
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
Time frame: study endpoint, up to 10 weeks
Change from Baseline in CAPS-5
3 secondary outcomes
CGI-S (Clinician Global Impression - Severity)
Time frame: study endpoint, up to 10 weeks
PGI-S (Patient Global Impression - Severity)
Time frame: study endpoint, up to 10 weeks
SDS (Sheehan Disability Scale)
Time frame: study endpoint, up to 10 weeks
Results and safety
The study was stopped early (reason given: company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NYX-783 in people with PTSD, run by Aptinyx at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition) (time frame: study endpoint, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.