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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05257265
Other study ID # 405-201-00016
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2, 2022
Est. completion date October 5, 2023

Study information

Verified date October 2023
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will be conducted to evaluate the efficacy and safety of the Centanafadine extended release (XR) capsules in adolescent subjects (13 - 17 years, inclusive) with ADHD.


Description:

The trial will consist of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.


Recruitment information / eligibility

Status Completed
Enrollment 459
Est. completion date October 5, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent. - A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI-KID. - A minimum symptoms total raw score of = 28 on the ADHD-RS-5 at baseline for all subjects. - A score of 4 or higher on the CGI-S-ADHD at baseline. Exclusion Criteria: - A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current major depressive episode. - Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP. - A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. History of suicidal behavior (over the last 6 months). - BMI = 40 kg/m2 or = 5th percentile for age and gender based on US CDC criteria. - Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
Centanafadine Hydrochloride
Capsule
Other:
Placebo
Capsule

Locations

Country Name City State
United States For additional information regarding sites, contact 844-687-8522 New York New York

Sponsors (1)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6. From baseline to week 6
Secondary Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Change from baseline in CGI-S-ADHD at Week 6 From baseline to week 6
Secondary Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6 From baseline to week 6
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