NCT04081363 is a Phase 2 clinical trial of Centanafadine in Attention Deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT04081363?

NCT04081363 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT04081363?

Interventions in NCT04081363: Centanafadine.

What condition does NCT04081363 study?

NCT04081363 studies Attention Deficit Hyperactivity Disorder.

Is NCT04081363 still recruiting?

NCT04081363 is currently completed. Last updated 13 January 2023.

Are results published for NCT04081363?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-13 · How we verify

NCT04081363

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)

Completed Phase 2 Results posted Last updated 13 January 2023

What this trial tests

Phase 2 trial testing Centanafadine in Attention Deficit Hyperactivity Disorder in 13 participants. Completed in 21 December 2019.

Timeline

7 October 2019

Primary endpoint
21 December 2019

21 December 2019

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	7 October 2019
Primary completion	21 December 2019
Estimated completion	21 December 2019
Sites	1 location across United States

Drugs / interventions tested

Centanafadine — full drug profile →

Conditions studied

Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 9 to 12, any sex, with 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.

Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Centanafadine Primary · 1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2

Group	Value	95% CI
Swallowed Capsules Cohort	153	± 51.4
Sprinkled Onto Applesauce Cohort	129	± 52.8

PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine Primary · 1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2

Group	Value	95% CI
Swallowed Capsules Cohort	3.03	2.00 – 10.00
Sprinkled Onto Applesauce Cohort	2.58	1.03 – 6.00

PK Parameter: Area Under Concentration-time Curve From Time 0 to 12 Hours Postdose (AUC0-12h) of Centanafadine Primary · 0 to 12 hours post dose on Day 1

Group	Value	95% CI
Swallowed Capsules Cohort	962	± 320
Sprinkled Onto Applesauce Cohort	828	± 346

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening up to last follow-up (approximately 30 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Swallowed Capsules Cohort

Serious: 0/7 (0%)

Deaths: 0/7

Sprinkled Onto Applesauce Cohort

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (1 terms — click to expand)

Reaction	System	Swallowed Capsules Cohort	Sprinkled Onto Applesauce …
Vessel Puncture Site Bruise	General disorders	—	—

Data from ClinicalTrials.gov NCT04081363 adverse events section.

Sponsor's own description

With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection in future trials.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Centanafadine

Trials testing the same drug.

NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT06973577 — P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety · Phase 3 · active not recruiting
NCT07486895 — Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects · Phase 1 · completed
NCT05536414 — Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder · Phase 2 · completed
NCT05113953 — A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder · Phase 2 · completed

Other recruiting trials for Attention Deficit Hyperactivity Disorder

Currently open trials in the same condition.

NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact · Phase 1 · recruiting
NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure · NA · recruiting
NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

NCT07525960 — A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for · Phase 1 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04081363 (US National Library of Medicine, public domain)
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: 13 January 2023

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/NCT04081363.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing