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

NCT06931080 | Recruiting Phase 2

• 1 other identifier: 405-102-00112
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

EB-1020(QD XR capsules) 164.4 mg

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) 164.4 mg

EB-1020(QD XR capsules) 328.8 mg

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) 328.8 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EB-1020 (Centanafadine) 164.4 mg DRUG

164.4 mg, capsule, oral, once daily, for 6 weeks

EB-1020(QD XR capsules) 164.4 mg

EB-1020 (Centanafadine) 328.8 mg DRUG

328.8 mg, capsule, oral, once daily, for 6 weeks

EB-1020(QD XR capsules) 328.8 mg

Placebo DRUG

Placebo, capsule, oral, once daily, for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Maynds Tower Mental Clinic

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

JP (1)