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The trial is taking place at:
E

Evolution Research Group | Richmond Behavioral Associates

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

E

Engrail Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Generalized Anxiety Disorder

Treatments

Drug: Placebo
Drug: ENX-102

Study type

Interventional

Funder types

Industry

Identifiers

NCT05749055
ENX-102-003

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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
  • Any past/lifetime or current diagnosis of a neurocognitive disorder, post traumatic stress disorder, obsessive compulsive disorder, psychotic disorder, or bipolar disorder
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups, including a placebo group

ENX-102
Experimental group
Description:
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.
Treatment:
Drug: ENX-102
Placebo
Placebo Comparator group
Description:
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.
Treatment:
Drug: Placebo

Trial contacts and locations

35

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Central trial contact

Eve Taylor, PhD

Data sourced from clinicaltrials.gov

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