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

NCT06653296 | Completed Phase 2

• 1 other identifier: ENX-102-004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

General Anxiety Disorder

Keywords

anxiety

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  • Incidence and severity of treatment-emergent AEs (TEAEs)

  4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

ENX-102 low-dose

EXPERIMENTAL

ENX-102

Drug: ENX-102

ENX-102 mid-dose

EXPERIMENTAL

ENX-102

Drug: ENX-102

ENX-102 high-dose

EXPERIMENTAL

ENX-102

Drug: ENX-102

Interventions

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

Also known as: ENX-102 low-dose, ENX-102 mid-dose, ENX-102 high-dose

ENX-102 high-dose; ENX-102 low-dose; ENX-102 mid-dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (3)

MAC Clinical Research

Liverpool, UK, United Kingdom

Location

MAC Clinical Research

Blackpool, United Kingdom

Location

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kimberly Vanover, PhD

  Engrail Therapeutics INC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: December 9, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)