What prior FDA approvals exist?

<p>ENX-102 has not yet been approved for the treatment of Generalized Anxiety Disorder.</p>

What other types of research exist?

<p>Promising novel alternatives to ENX-102 for GAD treatment include: 1) EGIS-10608, a 2,3-benzodiazepine with potent anxiolytic effects at low doses. 2) GD-23, an N-acyltryptophanyl-containing dipeptide with high anxiolytic-like effects comparable to diazepam. 3) LY354740, a metabotropic glutamate type 2 receptor agonist that has shown anxiolytic properties in clinical trials. These alternatives have demonstrated efficacy in preclinical or clinical studies and modulate neurotransmitter systems relevant to anxiety.</p>

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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

Are you willing and able to avoid alcohol or marijuana for the duration of the study?

Be older than 18 years old

Must not have

Have you been diagnosed with Schizophrenia?

Have you tried more than one anxiety medication that hasn't helped your symptoms?

Timeline

Screening 2 days

Treatment 9 weeks

Follow Up 1 week

Summary

This trial is testing a new medication called ENX-102 to see if it can help people with generalized anxiety disorder by reducing their anxiety symptoms.

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.

What is being tested?

ENX-102 is being tested for the treatment of Generalized Anxiety Disorder (GAD). ENX-102 is an investigational drug because its safety, effectiveness, and how it works are still being studied. ENX-102 will be compared to a placebo (“dummy” drug), which looks just like ENX-102 but does not contain any active ingredients. ENX-102 has not been approved as a treatment for any condition by government health authorities in any country.

What are the potential side effects?

ENX-102 has previously studied by Engrail. In those studies, ENX-102 was well tolerated, with the most common side effects being fatigue, dizziness and light-headedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 days2 visits

Treatment ~ 9 weeks3 visits

Follow Up ~ 1 week1 visit

Screening ~ 2 days

Treatment ~ 9 weeks

Follow Up ~1 week

This trial's timeline: 2 days for screening, 9 weeks for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

ENX-102 is an α2,3,5-subtype-selective modulator of the GABAA receptor that represents a potential new therapeutic modality for the treatment of anxiety and/or other disorders of the central nervous system (CNS) (Rudolf & Knoflach, 2011; Atack, 2010).

Effects of subchronic administration of antidepressants and anxiolytics on levels of the alpha subunits of G proteins in the rat brain.