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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention-Deficit/Hyperactivity Disorder | Drug: Centanafadine Hydrochloride Other: Placebo | Phase 3 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | 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.

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
United States, New York | |
For additional information regarding sites, contact 844-687-8522 | |
New York, New York, United States, 10012 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Centanafadine ADHD |
Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |