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NCT Number: NCT06926829

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

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

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maynds Tower Mental Clinic

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EB-1020 (Centanafadine) 164.4 mg

Drug

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

EB-1020 (Centanafadine) 328.8 mg

Drug

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

Primary outcomes

  1. Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline, week52

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Drug Information Center

CONTACT

+81-3-6361-7314

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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