Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753164
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Drug: ACT-539313 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : March 14, 2022
Estimated Study Completion Date : April 27, 2022

Arm Intervention/treatment
Experimental: 100 mg twice daily (b.i.d.) ACT-539313 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 Comparator: Placebo Drug: 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.




Primary Outcome Measures :
  1. Change from baseline to Week 12 in the number of binge eating (BE) days per week [ Time Frame: From baseline to Week 12; duration approx. 3 months ]
    A BE day is defined as a day with at least one confirmed BE episode.


Other Outcome Measures:
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: From the start of study treatment administration up to the End-of-Study (EOS); duration approx. 3.5 months ]
  2. Treatment-emergent serious AEs (SAEs) [ Time Frame: From the start of study treatment administration up to the End-of-Study (EOS); duration approx. 3.5 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2:

  • 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

- Female participants: pregnant, lactating or planning to become pregnant during the projected course of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753164


Contacts
Layout table for location contacts
Contact: Clinical Trial Disclosure Desk +41 58 844 1977 clinical-trials-disclosure@idorsia.com

Locations
Show Show 30 study locations
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
Layout table for additonal information
Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT04753164    
Other Study ID Numbers: ID-082A201
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive