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

NCT06926829 | Recruiting Phase 3

• 1 other identifier: 405-102-00113
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EB-1020 (QD XR Capsules) 164.4 mg

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) 164.4 mg

EB-1020 (QD XR Capsules) 328.8 mg

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) 328.8 mg

Interventions

EB-1020 (Centanafadine) 164.4 mg DRUG

164.4 mg, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) 164.4 mg

EB-1020 (Centanafadine) 328.8 mg DRUG

328.8 mg, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) 328.8 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Maynds Tower Mental Clinic

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 15, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

JP (1)