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Taking peoplePhase 2/3

Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients

Key facts

Who runs it
Otsuka Pharmaceutical Co., Ltd.
Where
Japan1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 2/3
People taking part
630 people, planned
Started
30 Apr 2025
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • EB-1020 (Centanafadine) 164.4 mg
  • EB-1020 (Centanafadine) 328.8 mg
  • Placebo
Record updated
23 October 2026

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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 take part

  • 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 who show a positive reaction in alcohol tests or urine drug tests at screening
  • Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants
  • Participants diagnosed with a personality disorder according to DSM-5 criteria
  • Participants diagnosed with autism spectrum disorder according to DSM-5 criteria
  • Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:; 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 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 are pregnant or breastfeeding, and those who test positive for pregnancy at screening
  • Participants diagnosed with intellectual disability and an IQ score below 70

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • EB-1020(QD XR capsules) 164.4 mgTreatment being tested

    Treatment: EB-1020 (Centanafadine) 164.4 mg

  • EB-1020(QD XR capsules) 328.8 mgTreatment being tested

    Treatment: EB-1020 (Centanafadine) 328.8 mg

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT06931080, who can take part
Record updated
23 October 2026