Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder
Phase 2
Completed
NCT01939353
| Condition | Adult ADHD |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 45 participants |
|---|
| Interventions | CTN SR |
|---|
| Start date | Oct 3, 2013 |
|---|
| Completion date | Feb 20, 2014 |
|---|
| Results posted | Oct 18, 2021 |
|---|
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.
Change From Baseline-2 in ADHD Symptoms to Week 4 as Assessed by the Adult Attention-Deficit Hyperactivity Disorder Rating Scale (AD HD-RS-IV)
Baseline, Week 4 · score on a scale
| Centanafadine SR 100-500 mg | 38.70 ± 6.19 score on a scale |
|---|
| Centanafadine SR 100-500 mg | -21.41 ± 10.74 score on a scale |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.