Attention Deficit/Hyperactivity Disorder
Conditions
Keywords
Centanafadine, ADHD
Brief summary
To evaluate long-term safety exposure
Detailed description
This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17 years). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until all enrolled subjects within the age group the subject was in at the start of their participation in the trial (13 to 17 years; 6 to 12 years; 4 to 5 years) have had a chance to reach the Week 52 visit.
Interventions
Capsule
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules. | Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination. |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed