Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Intervention: ACT-539313; Placebo
Intervention description: ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.; Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        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 1:

          -  BMI < 18.0 kg/m² or > 45 kg/m².

          -  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

          -  HAMD-17 score ≥ 17 points at Visit 1 and/or Visit 2.

          -  Any of the following conditions related to suicidality:

               1. Participant is considered to have a suicide risk in the investigator's opinion or
                  has a previous history of suicide attempt within the past 12 months.

               2. Participant answers "yes" to "suicidal ideation" item 4 (active suicidal ideation
                  with some intent to act, without specific plan) or item 5 (active suicidal
                  ideation with specific plan and intent) on the C-SSRS© assessment at Screening
                  (in the past month). Participants who answer "yes" to this question must be
                  referred to the investigator for follow-up evaluation.

          -  Female participants: pregnant, lactating or planning to become pregnant during the
             projected course of the study.