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

Last updated: July 30, 2025
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Autism

Treatment

EB-1020 (Centanafadine) 164.4 mg

EB-1020 (Centanafadine) 328.8 mg

Clinical Study ID

NCT06926829
405-102-00113
  • Ages 18-55
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who completed the treatment period andfollow-up period in the precedingdouble-blind parent Trial (Trial 405-102-00112) and did not meet the criteria fordiscontinuation 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

Exclusion Criteria:

  • Participants who are pregnant or breastfeeding or test positive for pregnancy onbaseline visit.

  • Participants who started prohibited concomitant medications/therapies for ADHD orother comorbidities at the end of the follow-up period of the preceding trial, orparticipants for whom starting treatment is deemed beneficial.

  • Participants who have a significant risk of committing suicide in the opinion of theinvestigator or subinvestigator, or based on the following evidence:

  • Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5on the section of suicidal ideation on the since last visit version of theColumbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blindparent trial or

  • Reported suicidal behavior

  • Participants who were found to have serious or severe adverse events that werejudged 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 baselinevisit.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: EB-1020 (Centanafadine) 164.4 mg
Phase: 3
Study Start date:
June 25, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Maynds Tower Mental Clinic

    Tokyo,
    Japan

    Active - Recruiting

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