Trials Sponsors Conditions Drugs Pricing

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) low dose

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) low dose

EB-1020 (QD XR Capsules) high dose

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) high dose

Interventions

EB-1020 (Centanafadine) low doseDrug

low dose, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) low dose

EB-1020 (Centanafadine) high doseDrug

high dose, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) high dose

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

\<Rollover participants\>
Participants who completed the 6-week treatment period and 1-week follow-up period in the preceding double-blind parent trial and did not meet the criteria for discontinuation of the IMP at Week 6.

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Hokkaido University Hospital

Sapporo, 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 DisordersNeurodevelopmental DisordersMental 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

July 24, 2025

First Posted

July 28, 2025

Study Start

September 16, 2025

Actual (reported)

Primary Completion

August 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

EB-1020 (QD XR Capsules) low dose

EB-1020 (QD XR Capsules) high dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

EB-1020 (QD XR Capsules) low dose

EB-1020 (QD XR Capsules) high dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations