RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Reunion Neuroscience Inc
- Study ID
- NCT07489651
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Generalized Anxiety Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- RE104 for Injection — DRUGSingle, subcutaneous dose of RE104 for Injection
- Placebo — DRUGSingle, subcutaneous dose of 0.9% sodium chloride for injection
Study Details
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
Key Dates
- Start date
- Apr 20, 2026
- Status verified
- May 2026
- Primary completion
- Feb 28, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboA single subcutaneous injection of 0.9% sodium chloride for injection
- Experimental: 30 mg RE104A single subcutaneous injection of 30 mg RE104 for Injection
Primary Outcome Measure
RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: Week 4 ]
Central Contacts
- Mark Pollack Chief Medical Officer, M.D.1-888-880-REUN
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lighthouse Psychiatry | Gilbert | Arizona | 85234 | |
| Open Mind Therapeutics | San Francisco | California | 94114 | |
| TRIP Clinic at Psychedelic Science Institute | Santa Monica | California | 90404 | Ashley Ramos |
| University of South Florida | Tampa | Florida | 33613 | |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | Michael Mahaffrey |
| UNM Research Program Psychedelic Therapies | Albuquerque | New Mexico | 14624 | |
| Summit Headlands LLC | Portland | Oregon | 97210 | Tyler Leecing |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | |
| Aim Trials, LLC | Plano | Texas | 75093 | |
| Cedar Clinical Research | Draper | Utah | 84020 | |
| Inner Space State Street | Orem | Utah | 84058 |
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