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

NCT04753164 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ID-082A201
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 30

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

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

100 mg twice daily (b.i.d.) ACT-539313

EXPERIMENTAL

Drug: ACT-539313

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACT-539313 DRUG

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.

100 mg twice daily (b.i.d.) ACT-539313

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (30)

Southern California Research

Beverly Hills, California, 90210, United States

Location

Wr-Pri, Llc

Encino, California, 91316, United States

Location

Collaborative Neuroscience Network (CNS)

Garden Grove, California, 92845, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Connecticut Clinical Research - Cromwell

Cromwell, Connecticut, 06416, United States

Location

Clinical Neurosciences Solutions

Jacksonville, Florida, 32256, United States

Location

Behavioral Clinical Research

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions Inc

Orlando, Florida, 31801, United States

Location

NeuorTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

Psych Atlanta P.C.

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Collective Medical Research

Prairie Village, Kansas, 66208, United States

Location

Harvard Medical School - McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials, Inc

Boston, Massachusetts, 02131, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

St. Charles Psychiatric Associates dba Midwest research group

Saint Charles, Missouri, 63304, United States

Location

M3 Wake Research

Las Vegas, Nevada, 89194, United States

Location

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, 03081, United States

Location

ActivMed Practices & Research

Portsmouth, New Hampshire, 03081, United States

Location

Bioscience Research

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

Location

The Medical Research Network

New York, New York, 10128, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Patient Priority Clinical Sites

Cincinnati, Ohio, 45221, United States

Location

University of Cincinnati College of Medicine - Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Oregon Center For Clinical Inv.

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

Salem, Oregon, 97304, United States

Location

Clinical Trials of Texas, Inc. (CTT)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

ACT-539313

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: Idorsia Clinical Trial Information
• Organization: Idorsia Pharmaceuticals Ltd

idorsiaclinicaltrials@idorsia.com

+18566613721

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: February 16, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 25, 2022
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)