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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2025-06-23

Brief Summary

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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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Detailed Description

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Conditions

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General Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

ENX-102 low-dose

ENX-102

Group Type EXPERIMENTAL

ENX-102

Intervention Type 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

ENX-102 mid-dose

ENX-102

Group Type EXPERIMENTAL

ENX-102

Intervention Type 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

ENX-102 high-dose

ENX-102

Group Type EXPERIMENTAL

ENX-102

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No