General Anxiety DisorderPhase 2NCT06653296
A Dose-Response Safety Study of ENX-102 in Patients With GAD
A Phase 2 study testing ENX-102 in people with General Anxiety Disorder, run by Engrail Therapeutics INC at 3 sites in United Kingdom.
Trial summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General 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
- 38 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Dec 2024to 23 Jun 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, 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
MAC Clinical Research
Blackpool
MAC Clinical Research
Liverpool, UK
MAC Clinical Research
Manchester
About this study
Official title: 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 is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD
- Conditions
- General Anxiety Disorder
- Being tested
- ENX-102, Placebo
- Keywords
- anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENX-102Drug
Also called ENX-102 low-dose, ENX-102 mid-dose, ENX-102 high-dose
Four weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period
PlaceboDrug
Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| ENX-102 low-dose | Experimental | ENX-102 Receives: Drug: ENX-102 |
| ENX-102 mid-dose | Experimental | ENX-102 Receives: Drug: ENX-102 |
| ENX-102 high-dose | Experimental | ENX-102 Receives: Drug: ENX-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
- Incidence and severity of treatment-emergent AEs (TEAEs)
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 posted22 Oct 2024
- Study start9 Dec 2024
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engrail Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Vanover, PhD, Study director, Engrail Therapeutics INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653296
- Sponsor's protocol ID
- ENX-102-004
- Status last verified
- Sep 2025
- First submitted
- 20 Oct 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06653296
- Acronym / sponsor ID
- ENX-102-004
- Conditions
- General Anxiety Disorder
- Keywords
- anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Engrail Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 Oct 2024 (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.
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| ENX-102 low-dose | Experimental | Drug: ENX-102ENX-102 |
| ENX-102 mid-dose | Experimental | Drug: ENX-102ENX-102 |
| ENX-102 high-dose | Experimental | Drug: ENX-102ENX-102 |
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, 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 (7 listed)
- 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
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-102Also: ENX-102 low-dose, ENX-102 mid-dose, ENX-102 high-doseFour weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period | Drug | ENX-102 high-dose, ENX-102 low-dose, ENX-102 mid-dose |
| PlaceboSix weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 4 weeks
• Incidence and severity of treatment-emergent AEs (TEAEs)
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 17 Sep 2025.
- 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.
Kimberly Vanover, PhD study director
Engrail Therapeutics INC
3 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 General Anxiety Disorder, run by Engrail Therapeutics INC at 3 sites in United Kingdom.
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 7 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Safety and tolerability (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 17 Sep 2025.