Evaluating EB-1020 for treating adult ADHD
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
PHASE2; PHASE3 · Otsuka Pharmaceutical Co., Ltd. · NCT06931080
This study is testing if a new medication called EB-1020 can help adults with ADHD manage their symptoms better than a placebo.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. (industry) |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06931080 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of two different doses of EB-1020, an oral medication, in adults diagnosed with ADHD. Participants will receive either the medication or a placebo once daily, and their responses will be monitored to determine the effectiveness of the treatment. The study will include individuals who meet specific diagnostic criteria for ADHD and will exclude those with certain psychiatric disorders or who are pregnant. The goal is to provide insights into how well EB-1020 can manage ADHD symptoms in adults.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with ADHD who meet specific scoring criteria and are either not currently on medication or are receiving treatment.
Not a fit: Patients with comorbid psychiatric disorders or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for managing ADHD symptoms in adults.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in treating ADHD with novel medications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tokyo
- Maynds Tower Mental Clinic — Tokyo, Japan (RECRUITING)
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Attention Deficit Hyperactivity Disorder