NCT06931080 Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
| NCT ID | NCT06931080 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Attention Deficit Hyperactivity Disorder (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 630 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 630 participants in total. It began in 2025-04-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Drug Information Center
📞 +81-3-6361-7314
Nobuhito Sanada
STUDY DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT06931080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Attention Deficit Hyperactivity Disorder (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06931080 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06931080 currently recruiting?
Yes, NCT06931080 is actively recruiting participants. Visit ClinicalTrials.gov or contact Otsuka Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT06931080 trial being conducted?
This trial is being conducted at Tokyo, Japan.
Who is sponsoring the NCT06931080 clinical trial?
NCT06931080 is sponsored by Otsuka Pharmaceutical Co., Ltd.. The principal investigator is Nobuhito Sanada at Otsuka Pharmaceutical Co., Ltd.. The trial plans to enroll 630 participants.