臨床研究等提出・公開システム

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

A Long-term Trial of EB-1020 in Adult Patients with ADHD

Sanada Nobuhito

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

OPC_EB-1020_P3@otsuka.jp

Drug Information Center

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

+81-3-6361-7314

opc_ctr@otsuka.jp

Recruiting

July. 16, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

1) 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).
2) 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.

1) Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
2) 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.
3) 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
4) 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.
5) Participants who test positive for drugs or alcohol in a urine test on baseline visit.

Both

Attention-Deficit Hyperactivity Disorder(ADHD)

Administer 1 or 2 EB-1020 164.4 mg capsules (corresponding to low or high dose) orally once daily,

Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)

+81-92-725-7900

Mar. 19, 2025

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. Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) 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. 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.

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