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A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

NCT05428033 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2026-04-13

No results posted yet for this study

Summary

This trial will be conducted to evaluate the efficacy of centanafadine once daily (QD) extended release (XR) versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

centanafadine capsule

capsule

OTHER

placebo capsule

capsule

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2025-03-17
Completion
2025-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428033 on ClinicalTrials.gov