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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (1)

Maynds Tower Mental Clinic
Tokyo, Japan