Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT06926829
A Long-term Trial of EB-1020 in Adult Patients With ADHD
A Phase 3 study testing EB-1020 (Centanafadine) 164.4 mg and EB-1020 (Centanafadine) 328.8 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- EB-1020 (Centanafadine) 164.4 mg and EB-1020 (Centanafadine) 328.8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteJapan
- Study dates
- 25 Jun 2025to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).
- Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.
Who cannot join
- Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
- Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.
- Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:
- Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or
- Reported suicidal behavior
- Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
- Participants who test positive for drugs or alcohol in a urine test on baseline visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drug Information Center contact
About this study
Official title: A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
- Being tested
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-1020 (Centanafadine) 164.4 mgDrug
164.4 mg, capsule, oral, once daily, for 52 weeks
EB-1020 (Centanafadine) 328.8 mgDrug
328.8 mg, capsule, oral, once daily, for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| EB-1020 (QD XR Capsules) 164.4 mg | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) 164.4 mg |
| EB-1020 (QD XR Capsules) 328.8 mg | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) 328.8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.
Measured: Baseline, week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start25 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926829
- Sponsor's protocol ID
- 405-102-00113
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.