A Long-term Trial of EB-1020 in Adult Patients With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder (ADHD). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug EB-1020 (Centanafadine) 164.4 mg
164.4 mg, capsule, oral, once daily, for 52 weeks - Drug EB-1020 (Centanafadine) 328.8 mg
328.8 mg, capsule, oral, once daily, for 52 weeks
Primary outcome measures
- Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs) [Time frame: Baseline, week52]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Maynds Tower Mental Clinic — Tokyo
Identifiers
NCT: NCT06926829 · 405-102-00113