A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
CompletedPhase 3Results postedLast updated 18 October 2021
What this trial tests
Phase 3 trial testing Centanafadine SR in Attention Deficit Disorder in 590 participants. Completed in 14 May 2020.
Adults 18 to 55, any sex, with Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS) Score at Day 42Primary· Baseline and Day 42
The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Mixed-effect model repeated measure (MMRM) was used for the analysis.
Group
Value
95% CI
Double-blind Treatment Period: Centanafadine SR 200 mg
-12.1
± 0.96
Double-blind Treatment Period: Centanafadine SR 400 mg
-12.5
± 0.99
Double-blind Treatment Period: Placebo
-8.07
± 0.94
Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Day 42Secondary· Baseline and Day 42
CGI-S is an observer-rated scale used to measure symptom severity with a total score range of 0 to 7 where 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
Group
Value
95% CI
Double-blind Treatment Period: Centanafadine SR 200 mg
-1.04
± 0.09
Double-blind Treatment Period: Centanafadine SR 400 mg
-0.99
± 0.09
Double-blind Treatment Period: Placebo
-0.71
± 0.09
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 59 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465731 — A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadi
· Phase 1
· completed
NCT03605849 — A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Atten
· Phase 3
· completed
NCT03605680 — A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attent
· Phase 3
· completed
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Currently open trials in the same condition.
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NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
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NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 18 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03605836.