Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Otsuka Pharmaceutical Co., Ltd.

Must not be taking: ADHD medication, Antidepressants

Disqualifiers: Pregnancy, Bipolar, Substance-related, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

630 Participants Needed

Trial Summary

What is the purpose of 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 adult ADHD patients.

Research Team

Nobuhito Sanada

Principal Investigator

Otsuka Pharmaceutical Co., Ltd.

Eligibility Criteria

Inclusion Criteria

I have been diagnosed with ADHD, not another type of attention disorder.

I am not on ADHD medication and scored 28 or higher on a test.

I am on ADHD medication and scored 22 or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EB-1020 QD XR capsules or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Participant Groups

Group I: EB-1020(QD XR capsules) 328.8 mg Experimental Treatment 1 Intervention

Group II: EB-1020(QD XR capsules) 164.4 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

206

Recruited

97,700+

Tarek Rabah

Otsuka Pharmaceutical Co., Ltd.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

John Kraus

Otsuka Pharmaceutical Co., Ltd.

Chief Medical Officer since 2021

MD and PhD in Neurobiology from Duke University