CLINICAL TRIALS PROFILE FOR CENTANAFADINE
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Clinical Trials for Centanafadine
Trial ID | Title | Status | Sponsor | Phase | Summary |
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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. |
NCT02547428 ↗ | Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) | Completed | Otsuka Pharmaceutical Development & Commercialization, 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. |
NCT02827513 ↗ | A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects | Terminated | Neurovance, Inc. | Phase 1 | The purpose of this study is to investigate the safety, tolerance, food effect, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended release (XR) formulations of Centanafadine (CTN) in Young Healthy participants. |
NCT03605680 ↗ | A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase 3 | This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo. |
NCT03605836 ↗ | A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase 3 | This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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 |
Attention-Deficit Hyperactivity Disorder | 2 |
[disabled in preview] | 0 |
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Clinical Trial Locations for Centanafadine
Trials by Country
Clinical Trial Progress for Centanafadine
Clinical Trial Phase
Clinical Trial Sponsors for Centanafadine
Sponsor Name