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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.

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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

FieldValue
Enrollment Target 450 participants
Start Date 2024-04-26
Est. Completion 2025-12
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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