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
Condition: Adult ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This Phase 2, flexible-dosage, single-blind exploratory study of CTN SR in adult male
      participants with ADHD consisted of a 1-week placebo run-in (SB), 4 weeks of treatment with
      CTN SR, and 2 weeks of follow-up. At the placebo run-in, participants must have had a score
      of greater than or equal to 28 on the Adult Attention-Deficit Hyperactivity Disorder Rating
      Scale Version IV (ADHD-RS-IV) to be eligible to continue participation in the study.

      At the end of single-blind placebo run-in treatment (that is, beginning of CTN SR treatment),
      the ADHD-RS-IV with adult prompts was re-administered. Participants who showed an improvement
      greater than or equal to 30% over baseline values or who had a score of less than 28 on the
      ADHD-RS-IV were withdrawn from the study prior to receiving any active drug. Those who showed
      less than 30% improvement from the placebo run-in to the beginning of CTN SR treatment
      continued the study. The consent form was phrased such that participants were not informed of
      the exact timing of CTN SR versus placebo treatment in order to maintain the blinded nature
      of the placebo treatment and reduce potential placebo effects. Dosing was flexible, with a
      target maximum dosage of 500 milligrams (mg) daily in divided doses (morning and afternoon,
      approximately 5 hours later) to be achieved if possible during Week 2 of CTN SR treatment.
      The participants took a starting dose of 100 mg of CTN SR daily; the dose was titrated in 100
      mg increments up to the maximum dosage of 500 mg daily. The treating physician escalated the
      dose to the maximum dose if participants had not achieved remission of ADHD in his/her
      judgment, and CTN SR was still well tolerated. If in the physician's judgment the participant
      could not tolerate further dose escalation, or was not tolerating the current dose well, the
      dose was maintained or reduced, with the goal of re-assessing dose and response at the
      subsequent visit for a possible increase in dose, until study completion.
    

Intervention name(s): CTN SR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CTN SR tablets; CTN SR-matching placebo tablets
Other intervention name(s): EB-1020 SR
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adult ADHD; centanafadine sustained release