EB-1020 for ADHD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Otsuka Pharmaceutical Co., Ltd.

Must not be taking: ADHD medication, Antidepressants

Disqualifiers: Pregnancy, Bipolar, Substance-related, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of two different doses of a new medication, EB-1020, for adults with ADHD. Participants will receive either one of the two doses of EB-1020 or a placebo (a look-alike pill with no active ingredients) for comparison. The trial seeks adults diagnosed with ADHD who either haven't been treated or have a certain level of symptoms. Those whose ADHD impacts daily life and meet specific diagnostic criteria might be a good fit for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in ADHD treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, like ADHD medication or antidepressants, if they are prohibited in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EB-1020 has been tested for safety in adults with ADHD. Previous studies found that the treatment is generally well-tolerated. Trials using doses between 200 mg and 400 mg per day demonstrated a good safety record in adults.

Another study tested EB-1020 for 52 weeks in children at high doses, suggesting that EB-1020 can be safe over time, even at higher doses.

While some side effects might occur, they are usually mild, such as minor headaches or slight stomach upset. These reactions are common with many medications. Safety data indicates that most people tolerate EB-1020 well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EB-1020 for adult ADHD because it offers a new approach compared to current treatments. Unlike the standard options like stimulants, which primarily enhance dopamine in the brain, EB-1020 is believed to target both norepinephrine and serotonin, potentially leading to fewer side effects and a more balanced treatment. This dual-action mechanism could make EB-1020 particularly promising for patients who don't respond well to traditional stimulant medications. Additionally, the extended-release (XR) capsule format provides once-daily dosing, which can improve convenience and adherence to treatment.

What evidence suggests that this trial's treatments could be effective for ADHD?

Studies have shown that EB-1020 appears promising for treating adult ADHD. In this trial, participants will receive either EB-1020 at a dose of 164.4 mg or 328.8 mg, or a placebo. Research indicates that this treatment balances certain brain chemicals, helping to improve focus and reduce impulsive behavior. Initial findings suggest that patients taking EB-1020 experienced significant improvements in their ADHD symptoms. Specifically, data from a study showed a noticeable change in a scale measuring symptom severity. These results suggest that EB-1020 could effectively manage ADHD in adults. ^{2 3 5 6 7}

Who Is on the Research Team?

Nobuhito Sanada

Principal Investigator

Otsuka Pharmaceutical Co., Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with ADHD, not another type of attention disorder.

I am not on ADHD medication and scored 28 or higher on a test.

I am on ADHD medication and scored 22 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EB-1020 QD XR capsules or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EB-1020

How Is the Trial Designed?

Group I: EB-1020(QD XR capsules) 328.8 mg Experimental Treatment 1 Intervention

Group II: EB-1020(QD XR capsules) 164.4 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

206

Recruited

97,700+

Tarek Rabah

Otsuka Pharmaceutical Co., Ltd.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

John Kraus

Otsuka Pharmaceutical Co., Ltd.

Chief Medical Officer since 2021

MD and PhD in Neurobiology from Duke University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07087327

NCT07087327 | A Long-term Trial of EB-1020 in Pediatric ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07086313

A Trial to Evaluate the Efficacy and Safety of EB-1020 in ... 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 ...

3. trialx.com trialx.com/clinical-trials/listings/306870/evaluation-of-the-efficacy-and-safety-of-eb-1020-in-adult-adhd-patients/

Evaluation of the Efficacy and Safety of EB-1020 in Adult ... 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 ...

4. adisinsight.springer.com adisinsight.springer.com/trials/700382091

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo ... 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

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9426730/

Efficacy, Safety, and Tolerability of Centanafadine ... The primary and key secondary efficacy endpoints were the change from baseline at day 42 in the Adult ADHD Investigator Symptom Rating Scale ( ...

6. dcchemicals.com dcchemicals.com/msds/MSDS_DC12318.html

Safe Data Sheet Avoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation. 7.2 ...

7. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-efficacy-and-safety-of-eb-1020-in-adult-adhd-patients

Evaluation of the Efficacy and Safety of EB-1020 in Adult ... 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 ...