Phase
Condition
Williams Syndrome
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Autism
Treatment
EB-1020 (Centanafadine) 164.4 mg
EB-1020 (Centanafadine) 328.8 mg
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who completed the treatment period andfollow-up period in the precedingdouble-blind parent Trial (Trial 405-102-00112) and did not meet the criteria fordiscontinuation 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
Exclusion Criteria:
Participants who are pregnant or breastfeeding or test positive for pregnancy onbaseline visit.
Participants who started prohibited concomitant medications/therapies for ADHD orother comorbidities at the end of the follow-up period of the preceding trial, orparticipants for whom starting treatment is deemed beneficial.
Participants who have a significant risk of committing suicide in the opinion of theinvestigator or subinvestigator, or based on the following evidence:
Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5on the section of suicidal ideation on the since last visit version of theColumbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blindparent trial or
Reported suicidal behavior
Participants who were found to have serious or severe adverse events that werejudged 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 baselinevisit.
Study Design
Connect with a study center
Maynds Tower Mental Clinic
Tokyo,
JapanActive - Recruiting

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