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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 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01939353
The ClinicalTrials.gov registry entry for NCT01939353 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01939353 reports 0 study locations.
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.
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