NCT03605836

A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 590 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.

Detailed description

Screening \& Washout Period: up to 28 days Investigational Treatment Period: 49 days Follow-up Period : 7 days or 10 days

Conditions

• Attention Deficit Disorder
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine SR	100 mg, BID, oral tablets
OTHER	Placebo	BID, oral tablet
DRUG	Centanafadine SR	200 mg, BID, oral tablets

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-05-14
• Completion: 2020-05-14
• First posted: 2018-07-30
• Last updated: 2021-10-18
• Results posted: 2021-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study