NCT01939353

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

An Exploratory, Single-Blind Pilot Trial of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 SR in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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improvement greater than or equal to 30% over baseline values or who had a score of less than 28 on the ADHD-RS-IV were withdrawn from the study prior to receiving any active drug.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.

Conditions

• Adult ADHD

Interventions

Type	Name	Description
DRUG	CTN SR	CTN SR tablets
DRUG	Placebo	CTN SR-matching placebo tablets

Timeline

• Start date: 2013-10-03
• Primary completion: 2014-02-20
• Completion: 2014-02-20
• First posted: 2013-09-11
• Last updated: 2021-10-18
• Results posted: 2021-10-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study