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A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.
Study Identifier:
405-201-00017
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Active, Not Recruiting
Study Details
Medical Condition
- ADHD
Study Drug
- Drug: Centanafadine Hydrochloride
Date
Feb 2022 - Apr 2026
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 4 - 18 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Rollover subjects from double-blind parent trials inclusion criteria:
- Subjects who completed the 6-week double-blind treatment period and the 7 (+2) day follow-up in a double-blind parent trial and who, in the opinion of the investigator, could potentially benefit from centanafadine QD XR for ADHD
- De novo subjects inclusion criteria:
- Males and females aged 4 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.
- A score of 4 or higher on the CGI-S-ADHD at baseline.
- Subjects aged 4 or 5 years only; has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.
- Rollover subjects from double-blind parent trials exclusion criteria:
- Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.
- De novo subjects exclusion criteria:
- A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder (adolescents only), Anorexia (adolescents only), Bulimia (adolescents only), Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), MDD with current major depressive episode, or has required treatment within the 3 months prior to screening, or in investigator's opinion, MDD may worsen or could be expected to require treatment during the course of this trial.
- 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).
- Body weight \< 13 kg
- BMI ≥ 40 kg/m2
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or are anticipated to start new treatment during the trial.
Protocol Summary
To evaluate long-term safety exposure
Study Locations
Location
Status
Location
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
Status
N/A
Location
The Center for Clinical Trials, Inc.
Saraland, Alabama, United States, 36571
Status
N/A
Location
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
Status
N/A
Location
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Care Access
Beverly Hills, California, United States, 90212
Status
N/A
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© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.
July 2025 01US25EUC0279
Requirements information
Inclusion criteria
- Rollover subjects from double-blind parent trials inclusion criteria:
- Subjects who completed the 6-week double-blind treatment period and the 7 (+2) day follow-up in a double-blind parent trial and who, in the opinion of the investigator, could potentially benefit from centanafadine QD XR for ADHD
- De novo subjects inclusion criteria:
- Males and females aged 4 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.
- A score of 4 or higher on the CGI-S-ADHD at baseline.
- Subjects aged 4 or 5 years only; has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.
- Rollover subjects from double-blind parent trials exclusion criteria:
- Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.
- De novo subjects exclusion criteria:
- A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder (adolescents only), Anorexia (adolescents only), Bulimia (adolescents only), Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), MDD with current major depressive episode, or has required treatment within the 3 months prior to screening, or in investigator's opinion, MDD may worsen or could be expected to require treatment during the course of this trial.
- 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).
- Body weight \< 13 kg
- BMI ≥ 40 kg/m2
- Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or are anticipated to start new treatment during the trial.