Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001128381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/07/2026
Date registered
Help: Date registered
10/09/2026
Date last updated
Help: Date last updated
28/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2a clinical research trial evaluating an investigational study drug (GlyphAgo/SPT-320) in adults with generalized anxiety disorder (GAD) and sleep disturbance.
Scientific title
A 6-Week, Multicenter, Monotherapy Trial to Evaluate the Effect of GlyphAgo on Sleep and Anxiety Symptoms in Participants With Generalized Anxiety Disorder and Insomnia Symptoms
Additional trial identifiers [1] 317634 0
SPT-320-2026-201
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12625000685415 is the Phase 1 determining doses used for this Phase 2a study.

Health condition
Health condition(s) studied:
Generalized Anxiety Disorder with Insomnia Symptoms 342405 0
Condition category
Condition code
Mental Health 338537 338537 0 0
Anxiety
Mental Health 338538 338538 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This Phase 2a, randomized, double-blind, multicenter study is designed to evaluate the efficacy, safety, and tolerability of GlyphAgo in adults with Generalized Anxiety Disorder (GAD) who experience insomnia symptoms. Participants will be screened for eligibility and will undergo baseline assessments, including at-home overnight EEG sleep monitoring. Eligible participants will be randomly assigned to receive one of two dose levels of GlyphAgo (16 mg/day or 32 mg/day) for 6 weeks. The study will assess the effects of treatment on objective sleep parameters, insomnia symptoms, and overall clinical outcomes using EEG-based sleep measurements and standardized clinical assessments. A 1-week safety follow-up period will be conducted after completion of treatment.

Experimental Arm 1: GlyphAgo 16 mg/day Participants will receive GlyphAgo 16 mg orally once daily for 6 weeks.
Adherence to intervention is monitored through drug capsule return.

Route of Administration being Oral.

Throughout the study, participants will undergo regular efficacy, safety, and tolerability assessments, including repeated at-home overnight EEG recordings to evaluate changes in sleep quality and other sleep-related outcomes.
Participants will be required to record in participants own home for 5 nights, once at baseline, week 2 and week 6 with a self-administered wearable wireless EEG headband. . Adherence will be monitored by app analytics.


Intervention code [1] 334453 0
Treatment: Drugs
Description of the comparator or control
Two oral dose regimens of GlyphAgo administered once daily orally for 6 weeks. Dose levels were determined based on Phase 1 pharmacokinetic and safety data, within the dose range evaluated in the Phase 1 program.

Experimental Arm 2: GlyphAgo 32 mg/day Participants will receive GlyphAgo 32 mg orally once daily for 6 weeks. Adherence to intervention is monitored through drug capsule return.
Control group
Dose comparison

Outcomes
Primary outcome [1] 345815 0
To evaluate change in insomnia symptoms in participants with GAD treated with GlyphAgo for 6 weeks
Timepoint [1] 345815 0
Change from baseline in ISI at week 6 post-commencement of treatment
Secondary outcome [1] 463411 0
To evaluate change in anxiety symptoms in participants with GAD and insomnia symptoms treated with GlyphAgo
Timepoint [1] 463411 0
Baseline over time for 6 weeks post-commencement of treatment, measured at bi-weekly intervals
Secondary outcome [2] 463412 0
Evaluate change in insomnia symptoms in participants with GAD treated with GlyphAgo
Timepoint [2] 463412 0
Change from baseline in ISI at week 2 and week 4 post-commencement of treatment.
Secondary outcome [3] 465319 0
Evaluate agomelatine PK concentrations in trial participants
Timepoint [3] 465319 0
Pre-dose: Day 1, 15, 29 and 43 Post-dose: Day1, 4hour
Secondary outcome [4] 465320 0
Assess collectively for safety and tolerability of GlyphAgo in participants with GAD and insomnia symptoms
Timepoint [4] 465320 0
Adverse Events continuously from baseline to 6 weeks post-commencement of treatment. t.C-SSRS Screening, Day 1, Day 15, Day 29, Day 43; Vital signs, hematology, clinical chemistry or urinalysis Screening, Day 1, Day 15, Day 29, Day 43, Day 50; 12 lead ECG screening, Day 1, Day 15, Day 43
Secondary outcome [5] 465321 0
Exploratory: To evaluate sleep architecture in participants with GAD and insomnia symptoms treated with GlyphAgo
Timepoint [5] 465321 0
Assessments will be conducted at Baseline (prior to commencement of treatment), Week 2, and Week 6 post-commencement of treatment.

Eligibility
Key inclusion criteria
- Male and female participants between the ages of 18 and 65 years, inclusive, at the time of signing the ICF.
- Meets the DSM-5 diagnostic criteria of primary GAD
- Above mild severity of Anxiety
- Presence of insomnia symptoms
- Ability to adhere to lifestyle and substance restrictions
• Limit excessive caffeine intake
• Limit Alcohol
• Limit heavy tobacco use
• abstain from cannabis containing products
• abstain from restricted medications such as benzodiazepines
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Current or recent (within past 6 months prior to signing the ICF) DSM-5 psychiatric diagnosis other than GAD. Participants with comorbid agoraphobia, panic disorder, social anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, or specific phobia are allowed if, in the opinion of the Investigator, the diagnosis is not sufficiently prominent and active such that it may confound the assessment of symptoms of GAD.
- Current major depressive episode. A history of major depressive disorder without a current major depressive episode is acceptable as long as GAD is a primary diagnosis.
- History of drug or alcohol use disorder according to DSM-5 criteria within 12 months before signing the ICF.
- Other sleep disorders, eg, narcolepsy, idiopathic hypersomnia, circadian rhythm sleep disorder, sleep
-Known allergy, hypersensitivity or history inadequate response or intolerability to agomelatine, GlyphAgo, or its excipients.
-Clinically Significant risk of suicide or harm to self

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is Concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list will be prepared using statistical software package by a biostatistician. Stratified allocation based on baseline EEG.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2026
Actual
Date of last participant enrolment
Anticipated
30/10/2027
Actual
Date of last data collection
Anticipated
19/12/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322174 0
Commercial sector/Industry
Name [1] 322174 0
Seaport Therapeutics
Country [1] 322174 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Seaport Therapeutics
Address
Country
Australia
Secondary sponsor category [1] 325076 0
Commercial sector/Industry
Name [1] 325076 0
Novotech (Australia) Pty Limited
Address [1] 325076 0
Country [1] 325076 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320706 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320706 0
Ethics committee country [1] 320706 0
Australia
Date submitted for ethics approval [1] 320706 0
01/07/2026
Approval date [1] 320706 0
14/08/2026
Ethics approval number [1] 320706 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151350 0
Prof Paul Fitzgerald
Address 151350 0
Paratus clinical, 48 High St, Northcote VIC 3070
Country 151350 0
Australia
Phone 151350 0
+61392766552
Fax 151350 0
Email 151350 0
[email protected]
Contact person for public queries
Name 151351 0
Dan Engeler
Address 151351 0
Novotech (Australia) Pty Ltd, Level 13, 440 Collins Street, Melbourne Victoria 3000 Australia
Country 151351 0
Australia
Phone 151351 0
+61 3 9960 7958
Fax 151351 0
Email 151351 0
[email protected]
Contact person for scientific queries
Name 151352 0
Dan Engeler
Address 151352 0
Novotech (Australia) Pty Ltd, Level 13, 440 Collins Street, Melbourne Victoria 3000 Australia
Country 151352 0
Australia
Phone 151352 0
+61 3 9960 7958
Fax 151352 0
Email 151352 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.