Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD

Aptinyx

Status and phase: Terminated; Phase 3; Phase 2

Conditions: PTSD

Treatments: Drug: Placebo; Drug: NYX-783

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05181995

NYX-783-2009

Details and patient eligibility

About

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)

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

50 mg NYX-783 QD

Experimental group

Description:

50 mg NYX-783 QD

Treatment:

Drug: NYX-783

Placebo

Placebo Comparator group

Description:

Placebo QD

Treatment:

Drug: Placebo