Clinical trial NCT04753164: Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Binge-Eating Disorder
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week
timeFrame: From baseline to Week 12; duration approx. 3.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Southern California Research
state: California
city: Encino
country: United States
facility: Wr-Pri, Llc
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network (CNS)
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Cromwell
country: United States
facility: Connecticut Clinical Research - Cromwell
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neurosciences Solutions
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Atlanta
country: United States
facility: NeuorTrials Research Inc
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta P.C.
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Prairie Village
country: United States
facility: Collective Medical Research
state: Kansas
city: Belmont
country: United States
facility: Harvard Medical School - McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials, Inc
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates dba Midwest research group
state: Missouri
city: Las Vegas
country: United States
facility: M3 Wake Research
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Portsmouth
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC
state: New York
city: New York
country: United States
facility: The Medical Research Network
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
state: Ohio
city: Mason
country: United States
facility: University of Cincinnati College of Medicine - Lindner Center of HOPE
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center For Clinical Inv.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. (CTT)
state: Texas
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: