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Two pivotal phrase 3 centanafadine trials show positive outcomes for children and adolescents with ADHD.
On October 27, 2023, Otsuka Pharmaceutical announced positive results from 2 pivotal phase 3 trials of centanafadine, a norepinephrine, dopamine, and serotonin reuptake inhibitor, for adolescents and children with Attention-Deficit/Hyperactivity Disorder (ADHD).1
Roughly 6 million children and adolescents in the U.S. have ADHD, but there is no cure for the disorder.2 According to the Attention Deficit Disorder Association, about two-thirds or more of children with ADHD continue to face symptoms into adulthood.3 Centanafadine is under development for adult ADHD and major depressive disorder, and now, childhood ADHD.4 Otsuka Pharmaceutical, led by Jeffery Gilbert, has conducted a randomized, double-blind, 3-arm fixed-dose trial to examine centanafadine’s efficacy, safety, and tolerability for ADHD in children and adolescents.1
Results of the phase 3 trials, which examined use in patients aged 6-12 years and 13-17 years, suggest use of centanafadine was associated with improvement in ADHD Rating Scale (ADHD-RS-5) symptoms total score at 6 weeks.
“Otsuka is committed to finding novel solutions for complex, underserved medical needs,” said John Kraus, MD, PhD, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, Inc, in a press release. “We are pleased these pivotal Phase 3 results demonstrate centanafadine has the potential to offer a new treatment option for children and adolescents who live with ADHD, a condition that can affect every aspect of life.”1
To explore the effects of centanafadine in children and adolescents, both trials enrolled younger patients with a primary diagnosis of ADHD based on DSM-5 criteria, which was confirmed with MINI-KID. The first trial (NCT05257256) focused on teens aged 13 – 17 years old, and the second trial (NCT05428033) focused on children aged 6 – 12 years old.
For trial 1 and 2, participants were randomized to receive low-dose centanafadine, high-dose centanafadine, or placebo. The investigators determined the provided dose by body weight.
Topline results of the trials indicated a significant change from baseline to week 6 in ADHD-RS-5 symptoms total score. In the first trial, patients 13 – 17 years old had statistically significant improvements compared to placebo for the average effect of high and low dose (P = .0099), as well as the high dose (P = .0006) in centanafadine-treated groups. The low-dose centanafadine-treated group did not have statistical significance.
The second trial with patients aged 6 – 12 years old also revealed improvements from baseline on the ADHD-RS-5 scale. Like in the first trial, patients receiving centanafadine in the second trial had statistically significant improvements compared to the placebo for both the average effect of the high and low dose (P = .0039) and for the high-dose (P = .0008), but the low-dose centanafadine group did not have statistical significance.
For both trials, the investigators found improvements with centanafadine by week 1, and improvements continued as the trial progressed. Although a pooled analysis of the 2 studies observed side effects of decreased appetite, nausea, rash, fatigue, upper abdominal pain, and somnolence, the results of the trial showed safety and tolerability.
Otsuka Pharmaceutical has yet to release full study results, but the trial results will be submitted for scientific publication soon.