Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
- Registration Number
- NCT04753164
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
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.
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:
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 mg twice daily (b.i.d.) ACT-539313 ACT-539313 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week From baseline to Week 12; duration approx. 3.5 months BE days per week is defined as the number of diary days with at least one confirmed BE episode during the applicable 14-day time interval divided by the total number of diary days, times 7.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
NeuorTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Collaborative Neuroscience Network (CNS)
🇺🇸Garden Grove, California, United States
Wr-Pri, Llc
🇺🇸Encino, California, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
University of Cincinnati College of Medicine - Lindner Center of HOPE
🇺🇸Mason, Ohio, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Clinical Neuroscience Solutions Inc
🇺🇸Orlando, Florida, United States
Bioscience Research
🇺🇸Mount Kisco, New York, United States
The Medical Research Network
🇺🇸New York, New York, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
Boston Clinical Trials, Inc
🇺🇸Boston, Massachusetts, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
M3 Wake Research
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Trials of Texas, Inc. (CTT)
🇺🇸San Antonio, Texas, United States
Oregon Center For Clinical Inv.
🇺🇸Portland, Oregon, United States
Southern California Research
🇺🇸Beverly Hills, California, United States
Connecticut Clinical Research - Cromwell
🇺🇸Cromwell, Connecticut, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Psych Atlanta P.C.
🇺🇸Marietta, Georgia, United States
Behavioral Clinical Research
🇺🇸North Miami, Florida, United States
Harvard Medical School - McLean Hospital
🇺🇸Belmont, Massachusetts, United States
ActivMed Practices & Research
🇺🇸Portsmouth, New Hampshire, United States
ActivMed Practices & Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Manhattan Behavioral Medicine PLLC
🇺🇸New York, New York, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
🇺🇸Salem, Oregon, United States
Clinical Neurosciences Solutions
🇺🇸Jacksonville, Florida, United States
St. Charles Psychiatric Associates dba Midwest research group
🇺🇸Saint Charles, Missouri, United States