The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

Phase 2

Waitlist Available

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, days 7, 14, 21, 28, 42, and 56

Summary

A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.

Eligible Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, days 7, 14, 21, 28, 42, and 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, days 7, 14, 21, 28, 42, and 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 7, 14, 21, 28, 42, and 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56

Other study objectives

Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts Score on Day 28 and Day 56

Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL) Total Score on Day 28 and Day 56

Change From Baseline in CAARS-O:SV 18-item Score on Days 7, 14, 21, 28, 42, and 56

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: OPC-64005Experimental Treatment2 Interventions

During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.

Group II: AtomoxetineActive Control2 Interventions

During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable.

Group III: PlaceboPlacebo Group1 Intervention

Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OPC-64005

2017

Completed Phase 2

~240

Placebo

1995