ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder

Sponsor

Engrail Therapeutics INC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05749055

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder	Drug: ENX-102 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The ENCALM Trial: A Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients With Generalized Anxiety Disorder

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ENX-102 Four weeks of 2 mg of ENX-102 in capsule form plus 2 weeks of placebo in capsule form (before and/or after the ENX-102 treatment period), taken orally once daily in the evening for a 6-week total treatment period.	Drug: ENX-102 Selective GABA-A alpha2,3,5 positive allosteric modulator
Placebo Comparator: Placebo Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period.	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: ENX-102

Four weeks of 2 mg of ENX-102 in capsule form plus 2 weeks of placebo in capsule form (before and/or after the ENX-102 treatment period), taken orally once daily in the evening for a 6-week total treatment period.

Drug: ENX-102

Selective GABA-A alpha2,3,5 positive allosteric modulator

Placebo Comparator: Placebo

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

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD) [4 weeks]
Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score [14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

Key Exclusion Criteria:

Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
Clinically significant psychiatric co-morbidities as assessed by the MINI
Reports moderately severe to severe symptoms of depression
Ingested psychotropic medication within 5 half-lives or 35 days (whichever is longer) prior to Screening, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
Recent suicidal ideation or behavior
Current or recent moderate to severe substance use disorder as assessed by the MINI
Clinically significant abnormal findings in safety assessments
Has significant progressive disorders or unstable medical conditions
Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Engrail Therapeutics INC

Investigators

Study Director: Estibaliz Arce, PhD, Engrail Therapeutics INC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Engrail Therapeutics INC

ClinicalTrials.gov Identifier:

NCT05749055

Other Study ID Numbers:

ENX-102-003

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 1, 2023