NCT06653296CompletedPhase 2
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)
Engrail Therapeutics INC1 site in 1 country38 target enrollmentStarted: December 9, 2024Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Engrail Therapeutics INC
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Safety and tolerability
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
ENX-102 low-dose
Experimental
ENX-102
Intervention: ENX-102 (Drug)
ENX-102 mid-dose
Experimental
ENX-102
Intervention: ENX-102 (Drug)
ENX-102 high-dose
Experimental
ENX-102
Intervention: ENX-102 (Drug)
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 4 weeks
• Incidence and severity of treatment-emergent AEs (TEAEs)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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