Attention Deficit Hyperactivity Disorder (ADHD)Phase 2/3NCT06931080
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
A Phase 2/3 study testing EB-1020 (Centanafadine) 164.4 mg and EB-1020 (Centanafadine) 328.8 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- EB-1020 (Centanafadine) 164.4 mg and EB-1020 (Centanafadine) 328.8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 630 participants
- Where
- 1 siteJapan
- Study dates
- 30 Apr 2025to Dec 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID).
- Participants with an AISRS total score meeting the following criteria:
- Not receiving medication treatment for ADHD: 28 points or higher
- Receiving medication treatment for ADHD: 22 points or higher
Who cannot join
- Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.
- Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder (current or lifetime), bipolar disorder (current or lifetime), generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.
- Participants diagnosed with a personality disorder according to DSM-5 criteria.
- Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.
- Participants diagnosed with intellectual disability and an IQ score below 70.
- Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:
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- Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a ""yes"" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline/Screening version at screening.
- Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria.
- Participants diagnosed with eating disorders and feeding disorders according to DSM-5 diagnostic criteria.
- Participants who show a positive reaction in alcohol tests or urine drug tests at screening.
- Participants with complications or a history of the following neurological disorders:
- Epilepsy
- Seizures (other than infantile febrile seizures)
- Syncope
- Tourette's disorder
- History of significant head trauma with clinically significant loss of consciousness
- Dementia
- Cerebrovascular disease
- Parkinson's disease
- Intracranial lesions
- Other severe neurological disorders
- Participants with complications or a history of cardiovascular diseases.
- Participants with clinical laboratory test results at screening that meet any of the following criteria:
- Platelets <= 75,000/mm3
- Hemoglobin <= 9 g/dL
- Neutrophils, absolute <= 1000/mm3
- AST > 2 x ULN
- ALT > 2 x ULN
- Creatinine >= 2 mg/dL
- CPK >= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator) •Abnormal values for both free T4 and TSH•
- Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drug Information Center contact
About this study
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of EB-1020 Once Daily QD XR Capsules Administered Orally at Low or High Dose in Adults With Attention-deficit/Hyperactivity Disorder
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.
- Being tested
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-1020 (Centanafadine) 164.4 mgDrug
164.4 mg, capsule, oral, once daily, for 6 weeks
EB-1020 (Centanafadine) 328.8 mgDrug
328.8 mg, capsule, oral, once daily, for 6 weeks
PlaceboDrug
Placebo, capsule, oral, once daily, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| EB-1020(QD XR capsules) 164.4 mg | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) 164.4 mg |
| EB-1020(QD XR capsules) 328.8 mg | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) 328.8 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6
The Adult Investigator Symptom Rating Scale (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). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
Measured: Baseline, Weeks 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start30 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931080
- Sponsor's protocol ID
- 405-102-00112
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.