A Long-term Trial of EB-1020 in Adult Patients With ADHD
Recruiting · NCT06926829 · Interventional (participants receive a specific treatment) · Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
EB-1020 (Centanafadine) 164.4 mgEB-1020 (Centanafadine) 328.8 mg
What this trial is about
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
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Maynds Tower Mental Clinic - Tokyo, Japan