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
第2相
完了
NCT01939353
| 対象疾患 | Adult ADHD |
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| 相 | 第2相 |
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| スポンサー | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 45 名 |
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| 介入（薬剤） | CTN SR |
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| 開始日 | 2013年10月3日 |
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| 完了日 | 2014年2月20日 |
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| 結果公開日 | 2021年10月18日 |
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概要
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.
Change From Baseline-2 in ADHD Symptoms to Week 4 as Assessed by the Adult Attention-Deficit Hyperactivity Disorder Rating Scale (AD HD-RS-IV)
Baseline, Week 4 · score on a scale
| Centanafadine SR 100-500 mg | 38.70 ± 6.19 score on a scale |
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| Centanafadine SR 100-500 mg | -21.41 ± 10.74 score on a scale |
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