Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
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
Interventions
164.4 mg, capsule, oral, once daily, for 52 weeks
328.8 mg, capsule, oral, once daily, for 52 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Contacts
Primary ContactDrug Information Center
Outcome results
None listed