CompletedPhase 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

United States45 participantsStarted 2013-10-03

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. Participants had to be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
✓. Participants must have met DSM-IV-TR diagnostic criteria for ADHD (Combined, Predominantly Inattentive or Predominantly Hyperactive-Impulsive Types) on the M.I.N.I.-Plus.
✓. Participants must have had an ADHD-RS-IV score of greater than or equal to 28 at the placebo run-in baseline and CTN SR treatment baseline.
✓. Participants must have had a Clinical Global Impression of Severity (ADHD version) score of greater than or equal to 4.
✓. Participants must be able to read well enough to understand the informed consent form and other participant materials.
✓. Participants must have been able to be reliably rated on the psychiatric scales required by the protocol based on investigator's judgment.
✓. Participants must have been able to read and understand English.
✓. Participants must have had a body mass index of approximately 18 to 35 kilograms/meter squared.

Exclusion criteria

What they're measuring

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)

Timeframe: Baseline, Week 4

Trial details

NCT IDNCT01939353

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02-20

Results submitted2021-09-20

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