Evaluating the safety of ENX-102 for treating anxiety
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)
This study is testing a new medication called ENX-102 to see if it is safe and helps adults with Generalized Anxiety Disorder feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Engrail Therapeutics INC Industry-sponsored |
| Locations | 3 sites (Liverpool, UK and 2 other locations) |
| Trial ID | NCT06653296 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of ENX-102 in patients diagnosed with Generalized Anxiety Disorder (GAD). The study aims to determine the dose-response relationship for ENX-102, which involves administering varying doses of the medication and comparing the effects to a placebo. Participants will be monitored for their anxiety symptoms and overall well-being throughout the trial. The study includes adults aged 18 to 65 who meet specific diagnostic criteria for GAD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with Generalized Anxiety Disorder experiencing significant anxiety symptoms.
Not a fit: Patients with predominant psychiatric diagnoses other than GAD or those with certain substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Generalized Anxiety Disorder.
How similar studies have performed: Other studies have shown promise in evaluating treatments for anxiety disorders, but the specific approach of ENX-102 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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 Key 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
Where this trial is running
Liverpool, UK and 2 other locations
- MAC Clinical Research — Liverpool, UK, United Kingdom (Recruiting)
- MAC Clinical Research — Blackpool, United Kingdom (Recruiting)
- MAC Clinical Research — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Eve M Taylor, PhD
- Email: eve.taylor@engrail.com
- Phone: 18583425478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.