High-dose centanafadine linked to higher chance of ADHD symptom improvement in children and teens
- In two phase 3 trials, high-dose centanafadine was associated with a higher chance of clinically meaningful improvement in ADHD core symptoms compared with placebo, although the low-dose group did not meet the primary endpoint.
- Children had a 55% higher chance of inattention improvement, while adolescents had a 65% higher chance.
- Compared to placebo, children treated with high-dose centanafadine had a 55% higher chance of experiencing clinically meaningful within-patient change in inattention.
- Adolescents treated with high-dose centanafadine had a 65% higher chance of experiencing clinically meaningful within-patient change in inattention.
- Children had a 48% higher chance of clinically meaningful improvement in hyperactivity/impulsivity, while adolescents had a 46% higher chance.
The publication
In two phase 3 trials, high-dose centanafadine was associated with a higher chance of clinically meaningful improvement in ADHD core symptoms compared with placebo, although the low-dose group did not meet the primary endpoint. Children had a 55% higher chance of inattention improvement, while adolescents had a 65% higher chance.
Who the findings apply to
The trials included children aged 6 to 12 years and adolescents aged 13 to 17 years with a primary diagnosis of ADHD.
Participants were randomized in a 1:1:1 ratio to receive once-daily extended-release high-dose centanafadine, low-dose centanafadine, or placebo.
The analysis focused on the high-dose centanafadine group, as the low-dose group did not meet the primary endpoint and was excluded from the presented results.
Why this matters
The study addresses the need for effective treatments for ADHD core symptoms in pediatric patients. Centanafadine, a norepinephrine, dopamine, and serotonin reuptake inhibitor, demonstrated efficacy in reducing inattention and hyperactivity/impulsivity as measured by Conners 3 scales. The results support the drug's role in managing persistent symptoms that interfere with daily functioning in children and adolescents.
What the study found
Compared to placebo, children treated with high-dose centanafadine had a 55% higher chance of experiencing clinically meaningful within-patient change in inattention.
Adolescents treated with high-dose centanafadine had a 65% higher chance of experiencing clinically meaningful within-patient change in inattention.
Children had a 48% higher chance of clinically meaningful improvement in hyperactivity/impulsivity, while adolescents had a 46% higher chance.
Significant improvements in inattention were observed at each study timepoint from Weeks 1 to 6, as reported by both caregivers and adolescents.
Hyperactivity/impulsivity was significantly improved in children and adolescents at each week from Weeks 1 to 6 based on caregiver reports, and at Weeks 4, 5, and 6 based on adolescent self-reports.
What the result does not establish
The low-dose centanafadine group did not meet the primary endpoint and was excluded from the analysis, so the results apply only to the high-dose formulation.
Because the low-dose data were excluded, the presented p-values are not controlled for multiplicity, which may affect the statistical interpretation of the findings.
The study was a secondary analysis of two phase 3 trials, and the results are based on specific clinical scales (Conners 3-Parent Short and Conners 3-Self-Report Short) over a 6-week treatment period.
Authors’ conclusion
“DISCUSSION: Centanafadine was efficacious in children and adolescents with ADHD, providing robust caregiver-reported and self-reported improvements when compared with placebo in the core symptoms of inattention, hyperactivity, and impulsivity. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT05257265 and NCT05428033.”
Study and sources
Clinically Meaningful Within-Patient Change in Core Attention-Deficit/Hyperactivity Disorder Symptoms in Children and Adolescents Treated With Centanafadine: Results From Two Phase 3 Randomized Clinical Trials
Randomised trial · Phase 3 · Journal of attention disorders · 2026-09-23
Sources and limitations
- PubMed record PMID 42779129 (PubMed / NLM · 2026-09-25)
- Trial registry NCT05257265 (ClinicalTrials.gov · 2026-09-25)
- Trial registry NCT05428033 (ClinicalTrials.gov · 2026-09-25)
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