CLINICAL TRIALS PROFILE FOR CENTANAFADINE

Clinical Trials for Centanafadine

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01939353 ↗	Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder	Completed	Neurovance, Inc.	Phase 2	This was a Phase 2 exploratory study to evaluate the efficacy and safety of EB-1020 SR (centanafadine sustained release [CTN SR]) in treating participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Attention-Deficit Hyperactivity Disorder (ADHD) on the Mini International Neuropsychiatric Interview Plus, Version 6.0 (M.I.N.I.-Plus). Evaluations included determining an effectiveness signal for ADHD and related symptoms and exploring dosing, tolerability, onset of action, and duration of effect. Dose-response/tolerability relationships with CTN SR were also explored. The 1-week placebo run-in [single-blind (SB)] was also used for informal safety comparison purposes.
NCT01939353 ↗	Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 2	This was a Phase 2 exploratory study to evaluate the efficacy and safety of EB-1020 SR (centanafadine sustained release [CTN SR]) in treating participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Attention-Deficit Hyperactivity Disorder (ADHD) on the Mini International Neuropsychiatric Interview Plus, Version 6.0 (M.I.N.I.-Plus). Evaluations included determining an effectiveness signal for ADHD and related symptoms and exploring dosing, tolerability, onset of action, and duration of effect. Dose-response/tolerability relationships with CTN SR were also explored. The 1-week placebo run-in [single-blind (SB)] was also used for informal safety comparison purposes.
NCT02547428 ↗	Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)	Completed	Neurovance, Inc.	Phase 2	This is a Phase IIb, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover study to evaluate safety, efficacy, and duration of efficacy of CTN SR BID target total daily dose (TDD) 400 mg compared with placebo in adults with ADHD.

Clinical Trial Conditions for Centanafadine

Condition Name

Condition Name for
Intervention	Trials
Attention Deficit Hyperactivity Disorder	5
Attention Deficit Disorder	3
Attention-Deficit Hyperactivity Disorder	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	12
Hyperkinesis	11
Disease	7

Clinical Trial Locations for Centanafadine

Trials by Country

Trials by Country for
Location	Trials
United States	17
Australia	1

Trials by US State

Trials by US State for
Location	Trials
New York	5
Florida	4
North Carolina	2
California	2
Nevada	2

Clinical Trial Progress for Centanafadine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	6
Phase 1	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for Centanafadine

Sponsor Name

Sponsor Name for
Sponsor	Trials
Otsuka Pharmaceutical Development & Commercialization, Inc.	14
Neurovance, Inc.	3

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	17