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

Otsuka Pharmaceutical Co., LTD.0 个研究点目标入组 180 人开始时间: 待定最近更新: 2025年4月28日

试验速览

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•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.

•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
•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.

Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)

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发起方