CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
CTN SR +1 moredrug
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.

Search/NCT01939353
NCT01939353Phase 2Completed

An Exploratory, Single-Blind Pilot Trial of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 SR in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 11, 2013·Updated May 19, 2026

In Brief

A Phase 2 clinical trial evaluating CTN SR and Placebo for Adult ADHD. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

This was a Phase 2 exploratory study to evaluate the efficacy and safety of EB-1020 SR (centanafadine sustained release \[CTN SR\]) in treating participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Attention-Deficit Hyperactivity Disorder (ADHD) on the Mini International Neuropsychiatric Interview Plus, Version 6.0 (M.I.N.I.-Plus). Evaluations included determining an effectiveness signal for ADHD and related symptoms and exploring dosing, tolerability, onset of action, and duration of effect. Dose-response/tolerability relationships with CTN SR were also explored. The 1-week placebo run-in \[single-blind (SB)\] was also used for informal safety comparison purposes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult ADHD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2013
Enrollment StartOct 3, 2013
Primary CompletionFeb 20, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.8 years ago

Interventions

CTN SRdrug

CTN SR tablets

Placebodrug

CTN SR-matching placebo tablets