A Long-term Trial of EB-1020 in Adult Patients With ADHD

A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder

The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: EB-1020 (Centanafadine) 164.4 mg; Drug: EB-1020 (Centanafadine) 328.8 mg

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Drug Information Center; Phone Number: +81-3-6361-7314

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Maynds Tower Mental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).
• Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.

Exclusion Criteria:

• Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
• Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.

• Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:

  • Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or
  • Reported suicidal behavior
• Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
• Participants who test positive for drugs or alcohol in a urine test on baseline visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EB-1020 (QD XR Capsules) 164.4 mg	Drug: EB-1020 (Centanafadine) 164.4 mg; 164.4 mg, capsule, oral, once daily, for 52 weeks
Experimental: EB-1020 (QD XR Capsules) 328.8 mg	Drug: EB-1020 (Centanafadine) 328.8 mg; 328.8 mg, capsule, oral, once daily, for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)	An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.	Baseline, week52

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Dyskinesias; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 405-102-00113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No