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NCT06413433 · ClinicalTrials.gov registry record · Phase 3
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
A Phase 3 study of Binge-Eating Disorder, sponsored by Axsome Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06413433 is a Phase 3 study of Binge-Eating Disorder that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 450 participants, below the 1,131-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT06413433, a Phase 3 study of Binge-Eating Disorder, is actively recruiting participants, sponsored by Axsome Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Solriamfetol 150 mg
- DRUG Solriamfetol 300 mg
Study Locations (20)
Florida
- Clinical Research Site - Clermont
- Clinical Research Site - Fort Myers
- Clinical Research Site - Hialeah
- Clinical Research Site - Jacksonville
- Clinical Research Site - Lauderhill
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami Lakes
- Clinical Research Site - Orlando
- Clinical Research Site - Orlando
California
- Clinical Research Site - Encino
- Clinical Research Site - Garden Grove
- Clinical Research Site - Long Beach
- Clinical Research Site - Newport Beach
- Clinical Research Site - San Diego
- Clinical Research Site - Santa Ana
- Clinical Research Site - Walnut Creek
- Clinical Research Site - West Covina
Colorado
- Clinical Research Site - Colorado Springs
Connecticut
- Clinical Research Site - Cromwell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-04-26 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06413433
The ClinicalTrials.gov registry entry for NCT06413433 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,131-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (60% lower). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Binge-Eating Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06413433 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06413433 about?
NCT06413433 is a clinical study titled "Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol". ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
What is the current status of trial NCT06413433?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-04-26. Estimated completion is 2025-12.
What conditions does trial NCT06413433 study?
This clinical trial studies the following conditions: Binge-Eating Disorder.
What interventions are being tested in trial NCT06413433?
The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 mg (DRUG), Solriamfetol 300 mg (DRUG).
Who is sponsoring clinical trial NCT06413433?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06413433 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.