Generalized Anxiety DisorderPhase 2ENCALMNCT05749055
ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder
A Phase 2 study testing ENX-102 in people with Generalized Anxiety Disorder, run by Engrail Therapeutics INC at 32 sites in United States.
Trial summary
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- ENX-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 32 sitesUnited States
- Study dates
- 3 Jul 2023to 18 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
- Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
- Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1
Who cannot join
- Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
- Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
- Reports moderately severe to severe symptoms of depression
- Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
- Recent suicidal ideation or behavior
- Current or recent moderate to severe substance use disorder as assessed by the MINI
Show all 9Show fewer
- Clinically significant abnormal findings in safety assessments
- Has significant progressive disorders or unstable medical conditions
- Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Austin Clinical Trials Partners
Austin, Texas, 78737
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Neurobehavioral Research
Cedarhurst, New York, 11516
Vertex Clinical Research
Clermont, Florida, 34711
Alpine Research Organization
Clinton, Utah, 84015
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Mountain View Clinical Research
Denver, Colorado, 80209
Core Clinical Research
Everett, Washington, 98201
Precise Research Centres
Flowood, Mississippi, 39232
Collaborative Neuroscience Research, LLC (CNS)
Garden Grove, California, 92845
Baylor College of Medicine
Houston, Texas, 77030
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Accel Research Sites Network - Lakeland CRU
Lakeland, Florida, 33803
IMA Clinical Research
Las Vegas, Nevada, 89102
Alliance Research
Long Beach, California, 90712
NRC Research Institute
Los Angeles, California, 90015
Accel Research Sites Network - Maitland CRU
Maitland, Florida, 32751
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Excell Research, Inc.
Oceanside, California, 92056
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Collective Medical Research
Overland Park, Kansas, 66210
IMA Clinical Research Phoenix
Phoenix, Arizona, 85012
Aim Trials
Plano, Texas, 75093
Anderson Clinical Research
Redlands, California, 92374
CenExel iResearch, LLC
Savannah, Georgia, 31405
California Neuroscience Research, LLC
Sherman Oaks, California, 91403
Richmond Behavioral Associates
Staten Island, New York, 10314
Pacific Clinical Research Management Group
Upland, California, 91786
Sunwise Clinical Research
Walnut Creek, California, 94596
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
Official title: The ENCALM Trial: A Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients With Generalized Anxiety Disorder
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
- Conditions
- Generalized Anxiety Disorder
- Being tested
- ENX-102, Placebo
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENX-102Drug
Selective GABA-A alpha2,3,5 positive allosteric modulator
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ENX-102 | Experimental | 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. Receives: Drug: ENX-102 |
| Placebo | Placebo comparator | Nine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score [14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes]
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start3 Jul 2023
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engrail Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Estibaliz Arce, PhD, Study director, Engrail Therapeutics INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749055
- Sponsor's protocol ID
- ENX-102-003
- Acronym
- ENCALM
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENCALM Trial: A Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05749055
- Acronym / sponsor ID
- ENCALM / ENX-102-003
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Engrail Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENX-102 | Experimental | Drug: ENX-102Four 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. |
| Placebo | Placebo comparator | Drug: PlaceboNine weeks of placebo in capsule form taken orally once daily in the evening for a 9-week total treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
- Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
- Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1
Key exclusion criteria (9 listed)
- Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
- Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
- Reports moderately severe to severe symptoms of depression
- Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
- Recent suicidal ideation or behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENX-102Selective GABA-A alpha2,3,5 positive allosteric modulator | Drug | ENX-102 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD)
Time frame: 4 weeks
Mean change from baseline on the Hamilton Anxiety Rating Scale (HAM-A) total score [14 symptoms with each symptom scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 and higher scores representing worse outcomes]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estibaliz Arce, PhD study director
Engrail Therapeutics INC
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENX-102 in people with Generalized Anxiety Disorder, run by Engrail Therapeutics INC at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of ENX-102 versus placebo in patients with generalized anxiety disorder (GAD) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.