Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder
Led by Axsome Therapeutics, Inc. · Updated on 2025-11-21
450
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating solriamfetol, a drug that affects TAAR-1, dopamine, and norepinephrine, for treating binge eating disorder (BED) in adults. This Phase 3 trial is randomized, double-blind, and placebo-controlled, designed to assess both the effectiveness and safety of solriamfetol in people diagnosed with BED according to DSM-5 criteria. Participants will be randomly assigned to one of three groups: solriamfetol 150 mg, solriamfetol 300 mg, or placebo. Each participant will take their assigned tablets once daily for up to 12 weeks. The study compares these doses with placebo to understand the drug's impact on BED symptoms. During the 12-week treatment period, researchers will monitor changes in the number of binge eating episodes from the start of the study to week 12. Participants will also undergo assessments to check safety and adherence. The total duration of participation will be up to 12 weeks, during which the effects of the treatment will be carefully evaluated.
CONDITIONS
Brief Title
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of binge eating disorder according to DSM-5 criteria
- Provides written informed consent before any study procedures
- Male or female aged 18 to 55 years inclusive
You will not qualify if you...
- Prior exposure to solriamfetol (Sunosi) through clinical study or prescription
- Unable to comply with study procedures
- Medically inappropriate for study participation as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants take solriamfetol or placebo tablets once daily as part of the study treatment.
Trial Site Locations
Total: 45 locations
1
Clinical Research Site
Encino, California, United States, 91316
Actively Recruiting
2
Clinical Research Site
Garden Grove, California, United States, 92845
Actively Recruiting
3
Clinical Research Site
Long Beach, California, United States, 90806
Actively Recruiting
4
Clinical Research Site
Newport Beach, California, United States, 92660
Actively Recruiting
5
Clinical Research Site
San Diego, California, United States, 92103
Terminated
6
Clinical Research Site
Santa Ana, California, United States, 92705
Actively Recruiting
7
Clinical Research Site
Walnut Creek, California, United States, 94596
Actively Recruiting
8
Clinical Research Site
West Covina, California, United States, 91790
Actively Recruiting
9
Clinical Research Site
Colorado Springs, Colorado, United States, 80910
Actively Recruiting
10
Clinical Research Site
Cromwell, Connecticut, United States, 06416
Actively Recruiting
11
Clinical Research Site
Clermont, Florida, United States, 34711
Terminated
12
Clinical Research Site
Fort Myers, Florida, United States, 33912
Actively Recruiting
13
Clinical Research Site
Hialeah, Florida, United States, 33012
Actively Recruiting
14
Clinical Research Site
Jacksonville, Florida, United States, 32256
Actively Recruiting
15
Clinical Research Site
Lauderhill, Florida, United States, 33319
Actively Recruiting
16
Clinical Research Site
Miami, Florida, United States, 33145
Actively Recruiting
17
Clinical Research Site
Miami, Florida, United States, 33176
Actively Recruiting
18
Clinical Research Site
Miami Lakes, Florida, United States, 33016
Terminated
19
Clinical Research Site
Orlando, Florida, United States, 32801
Actively Recruiting
20
Clinical Research Site
Orlando, Florida, United States, 32806
Terminated
21
Clinical Research Site
Marietta, Georgia, United States, 30060
Actively Recruiting
22
Clinical Research Site
Overland Park, Kansas, United States, 66210
Actively Recruiting
23
Clinical Research Site
Boston, Massachusetts, United States, 02131
Actively Recruiting
24
Clinical Research Site
Methuen, Massachusetts, United States, 01844
Terminated
25
Clinical Research Site
Saint Charles, Missouri, United States, 63304
Actively Recruiting
26
Clinical Research Site
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
27
Clinical Research Site
Princeton, New Jersey, United States, 08540
Actively Recruiting
28
Clinical Research Site
Mount Kisco, New York, United States, 10549
Actively Recruiting
29
Clinical Research Site
New York, New York, United States, 10128
Actively Recruiting
30
Clinical Research Site
Raleigh, North Carolina, United States, 27607
Actively Recruiting
31
Clinical Research Site
Cincinnati, Ohio, United States, 45215
Actively Recruiting
32
Clinical Research Site
Mason, Ohio, United States, 45040
Actively Recruiting
33
Clinical Research Site
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
34
Clinical Research Site
North Canton, Ohio, United States, 44720
Terminated
35
Clinical Research Site
Portland, Oregon, United States, 97210
Actively Recruiting
36
Clinical Research Site
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
37
Clinical Research Site
Media, Pennsylvania, United States, 19063
Actively Recruiting
38
Clinical Research Site
Greenville, South Carolina, United States, 29615
Actively Recruiting
39
Clinical Research Site
North Charleston, South Carolina, United States, 29405
Actively Recruiting
40
Clinical Research Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
41
Clinical Research Site
Austin, Texas, United States, 73787
Actively Recruiting
42
Clinical Research Site
Austin, Texas, United States, 78731
Actively Recruiting
43
Clinical Research Site
Dallas, Texas, United States, 75231
Actively Recruiting
44
Clinical Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
45
Clinical Research Site
Draper, Utah, United States, 84020
Terminated
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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