None listed
Conditions
Brief summary
Agomelatine is a clinically validated medicine approved in some countries for the treatment of anxiety and depression, but its use has been limited because much of the drug is broken down by the liver before it reaches the bloodstream. GlyphAgo is an investigational oral prodrug of agomelatine designed to overcome this limitation and improve how the drug is absorbed in the body. This study will evaluate two doses of GlyphAgo to determine whether the potential sleep benefit in patients with anxiety symptoms and sleep disturbance, and whether it is safe and well tolerated.
Interventions
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
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.
Sponsors
Seaport Therapeutics
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed