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

Binge-Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753164
• Other study ID #: ID-082A201
• Status: Completed
• Phase: Phase 2
• Start date: February 16, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: March 2023
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 25, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	NeuorTrials Research Inc	Atlanta	Georgia
United States	Harvard Medical School - McLean Hospital	Belmont	Massachusetts
United States	Southern California Research	Beverly Hills	California
United States	Boston Clinical Trials, Inc	Boston	Massachusetts
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	Connecticut Clinical Research - Cromwell	Cromwell	Connecticut
United States	Wr-Pri, Llc	Encino	California
United States	Precise Research Centers	Flowood	Mississippi
United States	Collaborative Neuroscience Network (CNS)	Garden Grove	California
United States	Clinical Neurosciences Solutions	Jacksonville	Florida
United States	M3 Wake Research	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Psych Atlanta P.C.	Marietta	Georgia
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	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	Behavioral Clinical Research	North Miami	Florida
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions Inc	Orlando	Florida
United States	Oregon Center For Clinical Inv.	Portland	Oregon
United States	ActivMed Practices & Research	Portsmouth	New Hampshire
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Collective Medical Research	Prairie Village	Kansas
United States	St. Charles Psychiatric Associates dba Midwest research group	Saint Charles	Missouri
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	Syrentis Clinical Research	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week	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.	From baseline to Week 12; duration approx. 3.5 months