Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOtsuka Pharmaceutical Co., Ltd.
About this trial
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 orally in adult ADHD patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID).
Not receiving medication treatment for ADHD: 28 points or higher
Receiving medication treatment for ADHD: 22 points or higher
Disqualifiers
Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.
Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder (current or lifetime), bipolar disorder (current or lifetime), generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.
Participants diagnosed with a personality disorder according to DSM-5 criteria.
Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.
Trial design
Design model
Parallel
Treatments tested in this trial
EB-1020 (Centanafadine) 164.4 mg
Drug164.4 mg, capsule, oral, once daily, for 6 weeks
EB-1020 (Centanafadine) 328.8 mg
Drug328.8 mg, capsule, oral, once daily, for 6 weeks
Placebo
DrugPlacebo, capsule, oral, once daily, for 6 weeks
Treatment groups
630 Participants
are divided into 3 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
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6
The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
Time frame
Baseline, Weeks 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov