Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
NCT ID: NCT04753164
Last Updated: 2023-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2021-02-16
2022-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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100 mg twice daily (b.i.d.) ACT-539313
ACT-539313
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.
Placebo
Placebo
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.
Interventions
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ACT-539313
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Southern California Research
Beverly Hills, California, United States
Wr-Pri, Llc
Encino, California, United States
Collaborative Neuroscience Network (CNS)
Garden Grove, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, United States
Clinical Neurosciences Solutions
Jacksonville, Florida, United States
Behavioral Clinical Research
North Miami, Florida, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States
NeuorTrials Research Inc
Atlanta, Georgia, United States
Psych Atlanta P.C.
Marietta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Collective Medical Research
Prairie Village, Kansas, United States
Harvard Medical School - McLean Hospital
Belmont, Massachusetts, United States
Boston Clinical Trials, Inc
Boston, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
St. Charles Psychiatric Associates dba Midwest research group
Saint Charles, Missouri, United States
M3 Wake Research
Las Vegas, Nevada, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
ActivMed Practices & Research
Portsmouth, New Hampshire, United States
Bioscience Research
Mount Kisco, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
The Medical Research Network
New York, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, United States
University of Cincinnati College of Medicine - Lindner Center of HOPE
Mason, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center For Clinical Inv.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, United States
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ID-082A201
Identifier Type: -
Identifier Source: org_study_id
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