NCT07086313 A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
| NCT ID | NCT07086313 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Attention-Deficit Hyperactivity Disorder(ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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 pharmacological treatment for ADHD) or\>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening. * Participants with a symptom total raw score of\>=28 on the ADHD-RS-5 at baseline. * Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline. Exclusion Criteria: * Participants who have a positive pregnancy test result at baseline. * Participants determined to have the following diseases based on an interview using the MINI-KID. * Tourette's disorder * Panic disorder * Conduct disorder * Psychotic disorder * Post-traumatic stress disorder * Bipolar disorder * Participants with a gener