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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 between 18-65 years old?
Do you experience any physical anxiety symptoms (i.e. chest pain, feeling hot flashes, stomach aches)?
Must not have
Have you been in therapy in the last three months?
Have you recently consumed marijuana?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

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.

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 ~ 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)

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.

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
The most common treatments for Generalized Anxiety Disorder (GAD) often involve medications that modulate neurotransmitter systems such as serotonin, norepinephrine, and GABA. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels by inhibiting its reuptake, improving mood and reducing anxiety. Serotonin-norepinephrine reuptake inhibitors (SNRIs) also increase norepinephrine levels, providing additional calming effects. Benzodiazepines enhance the effect of GABA, an inhibitory neurotransmitter, leading to reduced anxiety and improved relaxation. Understanding these mechanisms is crucial for GAD patients as it helps tailor treatments to their specific neurochemical imbalances, potentially improving efficacy and reducing side effects.
Effects of subchronic administration of antidepressants and anxiolytics on levels of the alpha subunits of G proteins in the rat brain.

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: ENX-102, Placebo
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
~91 spots leftby Jun 2025