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NCT06926829 | RECRUITING | Attention Deficit Hyperactivity Disorder (ADHD)

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

Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention/treatment

EB-1020 (Centanafadine) 164.4 mg

EB-1020 (Centanafadine) 328.8 mg

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Long-term Trial of EB-1020 in Adult Patients With ADHD

Location Details

NCT06926829

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Japan,

Maynds Tower Mental Clinic

Tokyo, Japan,