Clinical Trial 46855

Garden Grove, CA 92845


Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder

Criteria assessed at Visit 1:

  • Signed and dated informed consent form prior to any study-mandated procedure.
  • Male or female study participants aged 18 to 55 years at the time of signing the informed consent form.
  • Binge-eating disorder (BED) in accordance with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria diagnosed using the Structured Clinical Interview for DSM-5 (SCID-5).
  • Self-reported BED severity of at least moderate level, defined as at least 4 BE episodes per week, on average, for a duration of at least 6 months.
  • BED in accordance with Eating Disorder Examination Questionnaire (EDE-Q).
  • Clinical Global Impression of Severity scale (CGI-S) score of ≥ 4.
  • For women of childbearing potential (WOCBP): Negative serum pregnancy test at Visit 1; agreement to undertake monthly urine or serum pregnancy tests during the study and up to the EOS visit; agreement to use an acceptable contraceptive method.

Criteria assessed at Visit 2:

  • Reporting ≥3 BE days for each of the 2 weeks prior to randomization as documented in the participant's BE diary and with BE diary entries completed for at least 6 days per week during this 2-week period (between Visit 1 and 2).
  • CGI-S score of ≥ 4.
  • For WOCBP: negative urine pregnancy test.

Qualified Participants May Receive:

Monetary compensation for participation.

Available At:

CNS Network - Garden Grove
12772 Valley View Street, Suite #3
Garden Grove, CA 92845
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.