A Dose-Response Safety Study of ENX-102 in Patients With GAD

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD

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Key information

Conditions

General Anxiety Disorder Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MAC Clinical Research, Liverpool, UK, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
Diagnosed with GAD according to the DSM-V, confirmed by MINI
Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key Exclusion Criteria:

Clinically predominant psychiatric diagnosis other than GAD per the MINI
Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
Ingested prohibited medication within 5 half-lives prior to Day 1
Current or recent moderate or severe substance use disorder as assessed by the MINI
Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
Has significant progressive disorders or unstable medical conditions
Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study

Treatment and study plan

ENX-102

Drug

Four weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period

Other names: ENX-102 low-dose, ENX-102 mid-dose, ENX-102 high-dose

Placebo

Drug

Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period

Primary outcomes

Safety and tolerability

Time frame: 4 weeks
- Incidence and severity of treatment-emergent AEs (TEAEs)

Sponsors and collaborators

Lead sponsor

Engrail Therapeutics INC

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ENX-102 and Determine a Dose-response for ENX-102 in Patients With Generalized Anxiety Disorder (GAD)

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 22, 2024
Registry last updated: Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed