← Back to Search

Norepinephrine-Dopamine Reuptake Inhibitor

Double-blind Treatment Period: Centanafadine SR 200 mg for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
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 up to 59 days
Awards & highlights
Pivotal Trial

Summary

This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 59 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 59 days 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 ADHD Investigator Symptom Rating Scale (AISRS)
Secondary study objectives
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S)
Other study objectives
ADHD Impact Module - Adult (AIM-A)
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Adult ADHD Self Report Scale (ASRS)
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Single-blind Run-in Period: PlaceboExperimental Treatment1 Intervention
Placebo-matching tablets BID (twice daily) on Day -7 through Baseline (Day -1).
Group II: Double-blind Treatment Period: Centanafadine SR 400 mgExperimental Treatment1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 400 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Group III: Double-blind Treatment Period: Centanafadine SR 200 mgExperimental Treatment1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine 200 mg SR tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Group IV: Double-blind Treatment Period: PlaceboPlacebo Group1 Intervention
Following Single-blind Run-in Period, participants with \<30% improvement on Adult ADHD Self Report Scale (ASRS) scale score were randomized to receive centanafadine SR matching placebo tablets BID orally on Day 1 through Day 42 in the Double-blind Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine SR
2019
Completed Phase 3
~1860

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
169,570 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,875 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~88 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top