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) 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 mgDrug

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

EB-1020 (QD XR Capsules) 164.4 mg

EB-1020 (Centanafadine) 328.8 mgDrug

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

EB-1020 (QD XR Capsules) 328.8 mg

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Otsuka Pharmaceutical Co., Ltd.
Industrylead

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 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

April 11, 2025

First Posted

April 15, 2025

Study Start

June 25, 2025

Actual (reported)

Primary Completion

December 2027

Estimated

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

A Long-term Trial of EB-1020 in Adult 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) 164.4 mg

EB-1020 (QD XR Capsules) 328.8 mg

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) 164.4 mg

EB-1020 (QD XR Capsules) 328.8 mg

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