NCT05257265CompletedPhase 3
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
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country459 target enrollmentStarted: February 2, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 459
- Locations
- 1
- Primary Endpoint
- Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Centanafadine 164.4 mg
Experimental
Participants received centanafadine hydrochloride 164.4 milligrams (mg) XR capsules, orally, QD up to 6 weeks.
Intervention: Centanafadine Hydrochloride (Drug)
Centanafadine 328.8 mg
Experimental
Participants received centanafadine hydrochloride 328.8 mg XR capsules, orally, QD up to 6 weeks.
Intervention: Centanafadine Hydrochloride (Drug)
Placebo
Placebo Comparator
Participants received centanafadine matching placebo capsules, orally, QD up to 6 weeks.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)(From baseline to week 6)
- Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6(From baseline to week 6)
Investigators
Study Sites (1)
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