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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2027-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EB-1020 (QD XR Capsules) 164.4 mg

Group Type EXPERIMENTAL

EB-1020 (Centanafadine) 164.4 mg

Intervention Type DRUG

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

EB-1020 (QD XR Capsules) 328.8 mg

Group Type EXPERIMENTAL

EB-1020 (Centanafadine) 328.8 mg

Intervention Type DRUG

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

Interventions

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EB-1020 (Centanafadine) 164.4 mg

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

Intervention Type DRUG

EB-1020 (Centanafadine) 328.8 mg

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No