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Taking peoplePhase 3

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

Key facts

Who runs it
Otsuka Pharmaceutical Co., Ltd.
Where
Japan1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
180 people, planned
Started
25 Jun 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • EB-1020 (Centanafadine) 164.4 mg
  • EB-1020 (Centanafadine) 328.8 mg
Record updated
23 October 2026

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 test positive for drugs or alcohol in a urine test on baseline visit
  • Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • EB-1020 (QD XR Capsules) 164.4 mgTreatment being tested

    Treatment: EB-1020 (Centanafadine) 164.4 mg

  • EB-1020 (QD XR Capsules) 328.8 mgTreatment being tested

    Treatment: EB-1020 (Centanafadine) 328.8 mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT06926829, who can take part
Record updated
23 October 2026