This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).
The trial consisted 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
459
Capsule
Capsule
For additional information regarding sites, contact 844-687-8522
New York, New York, United States
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.
Time frame: From baseline to week 6
Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)
Change from baseline in CGI-S-ADHD at Week 6
Time frame: From baseline to week 6
Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6
Time frame: From baseline to week 6
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