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

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: EB-1020 (Centanafadine) 164.4 mg; Drug: EB-1020 (Centanafadine) 328.8 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Drug Information Center; Phone Number: +81-3-6361-7314

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Maynds Tower Mental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo, capsule, oral, once daily, for 6 weeks
Experimental: EB-1020(QD XR capsules) 164.4 mg	Drug: EB-1020 (Centanafadine) 164.4 mg; 164.4 mg, capsule, oral, once daily, for 6 weeks
Experimental: EB-1020(QD XR capsules) 328.8 mg	Drug: EB-1020 (Centanafadine) 328.8 mg; 328.8 mg, capsule, oral, once daily, for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weeks 6

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Dyskinesias; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 405-102-00112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No