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

• 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

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

Sex: All, ages: 18 Years to 55 Years

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.

• Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.