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

Otsuka

Status and phase: Enrolling; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Drug: EB-1020 (Centanafadine) 328.8 mg; Drug: EB-1020 (Centanafadine) 164.4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926829

405-102-00113

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

EB-1020 (QD XR Capsules) 164.4 mg

Experimental group

Treatment:

Drug: EB-1020 (Centanafadine) 164.4 mg

EB-1020 (QD XR Capsules) 328.8 mg

Experimental group

Treatment:

Drug: EB-1020 (Centanafadine) 328.8 mg