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

Ki vehet részt

• 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

Ki nem vehet részt

• 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 test positive for drugs or alcohol in a urine test on baseline visit
• Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit
• 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