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NCT01939353 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01939353: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01939353 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01939353, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study 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.
Primary Outcome
The ADHD-RS-IV consists of 18 items with first 9 items assessing inattentive symptoms and the last 9 items assessing hyperactive-impulsive symptoms scored on a 4-point Likert-type severity scale with 0 (none), 1 (mild), 2 (moderate), and 3 (severe) with a total score ranging from 0 to 54. Baseline-2 is defined as an end of 1-week SB placebo run-in and beginning of treatment with CTN SR. A negative change from Baseline indicates improvement.
Interventions
- DRUG Placebo
- DRUG CTN SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-10-03 |
| Est. Completion | 2014-02-20 |
| Phase | Phase 2 |
What the finished NCT01939353 record still lists
NCT01939353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01939353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01939353 about?
NCT01939353 is a clinical study titled "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". 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-Defi...
What is the current status of trial NCT01939353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2013-10-03. Estimated completion is 2014-02-20.
What interventions are being tested in trial NCT01939353?
The interventions under investigation include: Placebo (DRUG), CTN SR (DRUG).
Who is sponsoring clinical trial NCT01939353?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01939353's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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