Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
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|ClinicalTrials.gov Identifier: NCT04753164|
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : May 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Binge-Eating Disorder||Drug: ACT-539313 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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)|
|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|
|Experimental: 100 mg twice daily (b.i.d.) 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||
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.
- 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.
- 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 ]
- 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 ]
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
|Contact: Clinical Trial Disclosure Desk||+41 58 844 email@example.com|
|Study Director:||Clinical Trials||Idorsia Pharmaceuticals Ltd.|