Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder

  • STATUS
    Recruiting
  • End date
    Apr 27, 2022
  • participants needed
    120
  • sponsor
    Idorsia Pharmaceuticals Ltd.
Updated on 18 August 2021

Summary

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

Details
Condition Binge eating, Binge Eating Disorder, binges
Treatment Placebo, ACT-539313
Clinical Study IdentifierNCT04753164
SponsorIdorsia Pharmaceuticals Ltd.
Last Modified on18 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Criteria assessed at Visit 2
Any acute or chronic-persistent psychiatric disorder other than BED diagnosed in the past, including anorexia nervosa, bulimia, psychotic disorders, bipolar disorder, hypomania, or dementia, as defined by the DSM-5 criteria or by the Mini International Neuropsychiatric Interview (MINI)
Use of any medications for the treatment of BED (including lisdexamfetamine [Vyvanse]), any other eating disorder, obesity, or weight gain, or any other medication that could result in weight gain or weight loss, including over-the-counter and herbal products, within 3 months prior to Screening
Any clinically unstable medical condition, significant medical disorder or acute illness that, in the investigator's opinion, could interfere with the participants ability to comply with study assessments or abide by study restrictions
Criteria assessed at Visit 1 and Visit 2
Female participants: pregnant, lactating or planning to become pregnant during the projected course of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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