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A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05257265
Recruitment Status : Completed
First Posted : February 25, 2022
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: Centanafadine Hydrochloride Other: Placebo Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder
Actual Study Start Date : February 2, 2022
Actual Primary Completion Date : September 29, 2023
Actual Study Completion Date : October 5, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Dose Centanafadine Hydrochloride
328.8 mg total daily dose
 Drug: Centanafadine Hydrochloride
Capsule
Other Name: Centanafadine QD XR
Experimental: Low Dose Centanafadine Hydrochloride
164.4 mg total daily dose
 Drug: Centanafadine Hydrochloride
Capsule
Other Name: Centanafadine QD XR
Placebo Comparator: Matching Placebo Other: Placebo
Capsule
Other Name: Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) [ Time Frame: From baseline to week 6 ]
    Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.


Secondary Outcome Measures :
  1. Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) [ Time Frame: From baseline to week 6 ]
    Change from baseline in CGI-S-ADHD at Week 6

  2. Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6 [ Time Frame: From baseline to week 6 ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05257265


Locations
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United States, New York
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10012
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT05257265    
Other Study ID Numbers: 405-201-00016
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
URL: https://clinical-trials.otsuka.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Centanafadine
ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases