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

October 23, 2023 updated by: Engrail Therapeutics INC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
        • Contact:
          • Phone Number: 501-221-8681
      • Rogers, Arkansas, United States, 72113
        • Recruiting
        • Woodland Research Northwest
        • Contact:
          • Phone Number: 1 479-927-3000
    • California
      • Culver City, California, United States, 90230
        • Recruiting
        • ProScience Research Group
        • Contact:
          • Phone Number: 424-227-8127
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Collaborative Neuroscience Research, LLC (CNS)
        • Contact:
          • Phone Number: 714-891-0971
      • Lafayette, California, United States, 94549
        • Recruiting
        • Sunwise Clincial Research
        • Contact:
          • Phone Number: 925-298-5147
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Synergy Research Center - San Diego
        • Contact:
          • Phone Number: 619-303-6130
      • Los Angeles, California, United States, 90015
        • Recruiting
        • NRC Research Institute
        • Contact:
          • Phone Number: 714-289-1100
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc.
        • Contact:
          • Phone Number: 760-758-2222
      • Redlands, California, United States, 92374
        • Recruiting
        • Anderson Clinical Research
        • Contact:
          • Phone Number: 909-792-9007
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • California Neuroscience Research, LLC
        • Contact:
          • Phone Number: 818-990-2671
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Vertex Clinical Research
        • Contact:
          • Phone Number: 352-404-7560
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Neuroscience Solutions, Inc.
        • Contact:
          • Phone Number: 904-281-5757
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Neuroscience Solutions, Inc.
        • Contact:
          • Phone Number: 407-425-5100
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Phone Number: 912-744-0800
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • Collective Medical Research
        • Contact:
          • Phone Number: 913-381-7180
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Boston Clinical Trials
        • Contact:
          • Phone Number: 617-477-4868
      • Methuen, Massachusetts, United States, 01844
        • Recruiting
        • ActivMed Practices & Research
        • Contact:
          • Phone Number: 978-655-7155
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Recruiting
        • CenExel HRI
        • Contact:
          • Phone Number: 888-437-4104
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • SPRI Clinical Trials, LLC
        • Contact:
          • Phone Number: 718-616-2247
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Neuroscience Solutions, Inc.
        • Contact:
          • Phone Number: 901-843-1045
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • Austin Clinical Trials Partners
        • Contact:
          • Phone Number: 512-521-0595
      • Dallas, Texas, United States, 75231
        • Recruiting
        • FutureSearch Trials of Dallas
        • Contact:
          • Phone Number: 214-361-7700
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Phone Number: 713-689-9856

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 21 days (whichever is longer) prior to Day 1, 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENX-102
Four weeks of 2 mg of ENX-102 in capsule form followed by 3 weeks of tapered dose 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 9-week total treatment period.
Drug: ENX-102
Selective GABA-A alpha2,3,5 positive allosteric modulator
Placebo Comparator: Placebo
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
Time Frame: 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]
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: Estibaliz Arce, 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)

July 3, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENX-102-003

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

Yes

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.

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