At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Centanafadinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase 2a, Multicenter, Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (9 to 12 Years, Inclusive) With Attention-deficit Hyperactivity Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 9, 2019·Updated Jan 13, 2023
In Brief
A Phase 2 clinical trial evaluating Centanafadine for Attention Deficit Hyperactivity Disorder. Completed, enrolled 13 participants across 1 site.
Detailed Summary
With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection in future trials.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionDec 2019
TodayJul 2026
First PostedSep 9, 2019
Enrollment StartOct 7, 2019
Primary CompletionDec 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.8 years ago
Interventions
Centanafadinedrug
Extended-release and immediate-release capsules.