RECRUITING

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

Talk to us

Conditions

Binge-Eating DisorderBinge eating disorderBEDSolriamfetolSunosiAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitorTrace amine-associated receptor 1 (TAAR1) agonist

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

Quick Facts

Study Start:2024-04-26
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary diagnosis of BED according to DSM-5 criteria.
  2. * Provides written informed consent to participate in the study before the conduct of any study procedures.
  3. * Male or female, aged 18 to 55 inclusive.
  1. * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  2. * Unable to comply with study procedures.
  3. * Medically inappropriate for study participation in the opinion of the investigator.

Contacts and Locations

Study Contact

Study Director
CONTACT
212-332-5061
sol-bed-301@axsome.com

Study Locations (Sites)

Clinical Research Site
Encino, California, 91316
United States
Clinical Research Site
Newport Beach, California, 92660
United States
Clinical Research Site
San Diego, California, 92103
United States
Clinical Research Site
Clermont, Florida, 34711
United States
Clinical Research Site
Jacksonville, Florida, 32256
United States
Clinical Research Site
Orlando, Florida, 32801
United States
Clinical Research Site
Orlando, Florida, 32806
United States
Clinical Research Site
Marietta, Georgia, 30060
United States
Clinical Research Site
Overland Park, Kansas, 66210
United States
Clinical Research Site
Methuen, Massachusetts, 01844
United States
Clinical Research Site
Saint Charles, Missouri, 63304
United States
Clinical Research Site
Cherry Hill, New Jersey, 08002
United States
Clinical Research Site
Raleigh, North Carolina, 27607
United States
Clinical Research Site
Memphis, Tennessee, 38119
United States
Clinical Research Site
Austin, Texas, 73787
United States
Clinical Research Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Axsome Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-26
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-04-26
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Binge eating disorder
  • BED
  • Solriamfetol
  • Sunosi
  • Axsome
  • Non-stimulant therapy
  • Dopamine norepinephrine reuptake inhibitor
  • Trace amine-associated receptor 1 (TAAR1) agonist

Additional Relevant MeSH Terms

  • Binge-Eating Disorder