A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

Recruiting Phase 2 Phase 3 Interventional Study
Attention-Deficit Hyperactivity Disorder(ADHD)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
315 (estimated)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
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About This Trial

The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD. * Participants with a symptom total raw score of\>=28 (if not receiving any phar…
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