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ENX-102 for Generalized Anxiety Disorder (ENCALM Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Engrail Therapeutics INC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

ENCALM Trial Summary

This trial will test a new drug to treat anxiety in people with GAD. It'll check how safe and effective it is.

Who is the study for?
The ENCALM trial is for adults aged 18-65 with Generalized Anxiety Disorder as per DSM-5, confirmed by interview. Participants must have significant anxiety needing treatment but no severe depression or substance use disorders. They shouldn't be on psychotropic meds recently and must be able to follow the study plan.Check my eligibility
What is being tested?
ENCALM is testing the effectiveness and safety of a new medication called ENX-102 compared to a placebo in treating Generalized Anxiety Disorder. Patients will randomly receive either ENX-102 or a placebo to see if there's an improvement in their anxiety symptoms.See study design
What are the potential side effects?
Possible side effects of ENX-102 are not detailed here, but generally, anti-anxiety medications can cause drowsiness, dizziness, nausea, headache, dry mouth, or trouble sleeping. The exact side effects will be monitored throughout the trial.

ENCALM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)

ENCALM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ENX-102Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period.

Find a Location

Who is running the clinical trial?

Engrail Therapeutics INCLead Sponsor
1 Previous Clinical Trials
Estibaliz Arce, PhDStudy DirectorEngrail Therapeutics INC

Media Library

ENX-102 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05749055 — Phase 2
Generalized Anxiety Disorder Research Study Groups: Placebo, ENX-102
Generalized Anxiety Disorder Clinical Trial 2023: ENX-102 Highlights & Side Effects. Trial Name: NCT05749055 — Phase 2
ENX-102 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05749055 — Phase 2
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05749055 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit for this trial set at eighty-five years or below?

"This research is open to candidates who are mature enough and young enough. Specifically, those over 18 years old but under 65 years old may participate in the study."

Answered by AI

What is the total participant pool size for this research project?

"This trial necessitates 200 participants meeting the selection criteria to participate, with sites such as Woodland Research Northwest in Rogers, California and ProScience Research Group in Culver City, Florida accepting enrollees."

Answered by AI

Is there the possibility of enrolment in this clinical research?

"The trial is actively recruiting, as indicated on clinicaltrials.gov, with the initial posting being made on July 3rd 2023 and most recently updated again on that same day."

Answered by AI

Does ENX-102 present any risks to patients when administered?

"Our evaluation gave ENX-102 a score of 2, as this is only in Phase 2 trials and thus has evidence backing its safety but not necessarily its efficacy."

Answered by AI

Are there a large number of health care facilities participating in this North American research project?

"Presently, 24 medical centres are participating in this trial. These locations include Rogers, Culver City and Garden Grove as well other sites throughout the country - it is advised that participants select a site close to them to reduce travelling demands."

Answered by AI

How can I participate in this research project?

"This trial is open to 200 individuals aged 18-65 that have been diagnosed with Generalized Anxiety Disorder according to DSM 5. To apply, they must meet the following criteria: any gender at birth (including all genders), confirmed via MINI 7.0.2, clinically significant levels of generalised anxiety and tension as evidenced by HAM-A scores ≥22 and item 1/2 both ≥ 2 on Screening day & Day 1 respectively."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
NRC Research Institute
Vertex Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Currently diagnosed with depression and anxiety. I've tried a few different medications including home remedies with no luck. I'm hoping this study will either help me find relief or help scientists get closer to finding something that will work good for me and others in the future.
PatientReceived 2+ prior treatments
~118 spots leftby Jun 2025