A Phase 3 interventional study of EB-1020 (Centanafadine) low dose and EB-1020 (Centanafadine) high dose in Attention-Deficit Hyperactivity Disorder(ADHD), sponsored by Otsuka Pharmaceutical Co., Ltd.. Recruiting at 1 site in Japan. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 20 studies testing centanafadine in Attention Deficit Disorder with Hyperactivity — 5 open to participants now, 5 under way, 5 of them phase 3. centanafadine · Attention Deficit Disorder with Hyperactivity.
Among the 20 studies testing centanafadine in Attention Deficit Disorder with Hyperactivity, this one is the 10th largest by planned enrollment, is one of 5 that started in 2025, is one of 10 in phase 3, and was the 16th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 180 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →5 of the 20 studies testing centanafadine in Attention Deficit Disorder with Hyperactivity are open now, in 2 countries. Each count lists the studies.
centanafadine: first FDA approval 2026 (SIMTRIYO). What it is approved for, and how studies give it, is on its page →
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2025.
Median enrollment 180 across the 20 interventional studies. Of the 15 that completed or were terminated, 4 (27%) have results posted.
20 of 20 have an industry lead sponsor. The 2 most frequent:
Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.
Otsuka Pharmaceutical Co., Ltd. has 4 studies filed under Attention Deficit Disorder with Hyperactivity — fewer than ten, so there is no comparison to draw.
3 of the studies testing centanafadine in Attention Deficit Disorder with Hyperactivity that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07759154Phase 3Otsuka Pharmaceutical Development & Commercialization, Inc.A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation | 2027-05-27 |
| NCT07087327Phase 3Otsuka Pharmaceutical Co., Ltd.A Long-term Trial of EB-1020 in Pediatric Patients With ADHD | 2027-08 |
| NCT07086313Phase 3Otsuka Pharmaceutical Co., Ltd.A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD | 2027-08 |
Among the 20 studies testing centanafadine in Attention Deficit Disorder with Hyperactivity, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in pediatric ADHD patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
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Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.
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Participants determined to have the following diseases based on an interview using the MINI-KID.
Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.
Participants who have laboratory test results at screening as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: EB-1020 (Centanafadine) low dose
Drug: EB-1020 (Centanafadine) high dose
low dose, capsule, oral, once daily, for 52 weeks
high dose, capsule, oral, once daily, for 52 weeks
Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.
Time frame: Baseline, week52
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Aug 2027, 23 months after the start.
Of 66 industry-sponsored phase 3 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 23 months is above that.
Counting every sponsor, half of 80 studies reached it within 14 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Centanafadine
Attention Deficit Disorder with Hyperactivity →
Otsuka Pharmaceutical Co., Ltd. →