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Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
Verified Trial
Phase 2 & 3
Waitlist Available
Research Sponsored by Aptinyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable allowed medications with no planned changes from 30 days prior to screening through study participation
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Timeline
Screening 3 weeks
Treatment Varies
Follow Up study endpoint, up to 10 weeks
Summary
This trial tests a daily pill called NYX-783 to see if it helps people with PTSD. The study will check if the drug is safe and effective in reducing PTSD symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
The study participants can take stable medications without any changes for 30 days before the screening process and during the duration of the study.
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This is not an exclusion criterion. It is a question to gather information about the participant.
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What is your weight in pounds?
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You must agree to use very effective birth control during the study.
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You agree to attend all scheduled visits and follow the study procedures.
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You have been diagnosed with post-traumatic stress disorder (PTSD) according to the DSM-5 criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study endpoint, up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study endpoint, up to 10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
Secondary study objectives
CGI-S (Clinician Global Impression - Severity)
PGI-S (Patient Global Impression - Severity)
SDS (Sheehan Disability Scale)
Side effects data
From 2020 Phase 2 trial • 160 Patients • NCT040446644%
Headache
4%
Urinary Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
NYX-783 High Dose (50 mg QD)
NYX-783 Low Dose (10 mg QD)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg NYX-783 QDExperimental Treatment1 Intervention
50 mg NYX-783 QD
Group II: PlaceboPlacebo Group1 Intervention
Placebo QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NYX-783
2019
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
AptinyxLead Sponsor
8 Previous Clinical Trials
1,213 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
65 Previous Clinical Trials
14,739 Total Patients Enrolled