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RECRUITING Phase 3

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

NCT06413433 · View on ClinicalTrials.gov ↗

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

11 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06413433 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06413433?

The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 mg (DRUG), Solriamfetol 300 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06413433?

This trial is sponsored by Axsome Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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