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

September 16, 2025 updated by: Engrail Therapeutics INC

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Blackpool, United Kingdom
        • MAC Clinical Research
      • Manchester, United Kingdom
        • MAC Clinical Research
    • UK
      • Liverpool, UK, United Kingdom
        • MAC Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period
Experimental: ENX-102 low-dose
ENX-102
Drug: ENX-102
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
Experimental: ENX-102 mid-dose
ENX-102
Drug: ENX-102
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
Experimental: ENX-102 high-dose
ENX-102
Drug: ENX-102
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 4 weeks
• Incidence and severity of treatment-emergent AEs (TEAEs)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Engrail Therapeutics INC

Investigators

  • Study Director: Kimberly Vanover, PhD, Engrail Therapeutics INC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Actual)

June 23, 2025

Study Completion (Actual)

June 23, 2025

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

October 20, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENX-102-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on General Anxiety Disorder

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe