A Long-term Trial of EB-1020 in Adult Patients With ADHD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOtsuka Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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
Trial design
Design model
Parallel
Treatments tested in this trial
EB-1020 (Centanafadine) 164.4 mg
Drug164.4 mg, capsule, oral, once daily, for 52 weeks
EB-1020 (Centanafadine) 328.8 mg
Drug328.8 mg, capsule, oral, once daily, for 52 weeks
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: EB-1020 (QD XR Capsules) 164.4 mgExperimental treatment 1 intervention
Group B: EB-1020 (QD XR Capsules) 328.8 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, week52Sponsors and contacts
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Source ClinicalTrials.gov