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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 07 Jun 2022

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At a glance

  • Drugs Centanafadine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 02 Jun 2022 Results of two studies (NCT03605680 and NCT03605836) assessing efficacy and safety profiles of 200 mg/d and 400 mg/d centanafadine in adults with Attention-Deficit/Hyperactivity Disorder, published in the Journal of Clinical Psychopharmacology.
    • 11 Jun 2020 Primary endpoint (Adult ADHD Investigator Symptom Rating Scale (AISRS): 200 mg and 400 mg total, daily oral doses of centanafadine vs. placebo) has been met, according to an Otsuka Pharmaceutical media release.
    • 11 Jun 2020 Top-line results from two, six-week, phase 3 clinical trials presented in an Otsuka Pharmaceutical media release.
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