Abstract:
PURPOSE:The limitations of current US Food and Drug Administration (FDA)-approved medications for the treatment of attention-deficit/hyperactivity disorder (ADHD) set the need for the development of novel, effective, and tolerable medications to treat this disorder. The purpose of this study was to evaluate whether treatment with SPN-812 (viloxazine extended-release) significantly reduces symptoms of ADHD in children. METHODS:This study was a randomized, double-blind, placebo-controlled 6-week trial to assess the efficacy and safety of once-daily 100- and 200-mg SPN-812 in the treatment of ADHD in male and female children 6-11 years of age. Inclusion criteria required subjects to have a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, ADHD diagnosis, an ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, a Clinical Global Impression-Severity score ≥4, and for subjects to be free of ADHD medication ≥1 week before randomization. The primary efficacy endpoint was the change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 Total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) scores at EOS and CFB at EOS in the Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) Total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, ECGs, and the Columbia-Suicide Severity Rating Scale. The primary efficacy endpoint was analyzed by using a mixed model for repeated measures; all secondary measures were analyzed by using an ANCOVA model. RESULTS:A total of 477 subjects were randomized to treatment (intent-to-treat population, n = 460). The majority of subjects were male (63%) and either White (51.3%) or African American (43.7%). The demographic and baseline characteristics between the groups were similar. Statistically significant improvements in ADHD-RS-5 Total score were observed in both the 100- and 200-mg/day SPN-812 treatment groups compared to placebo at week 1 of treatment (P = 0.0004 and P = 0.0244, respectively), which was maintained through EOS (P = 0.0004 and P < 0.0001). Significant improvements were also observed at EOS in the CGI-I scale (P = 0.0020 and P < 0.0001), Conners 3-PS Composite T-score (P = 0.0003 and P = 0.0002), and WFIRS-P Total average score (P = 0.0019 and P = 0.0002) versus placebo. Treatment-related AEs reported in ≥5% of subjects included somnolence, decreased appetite, and headache. The discontinuation rate due to AEs was <5%. IMPLICATIONS:SPN-812 significantly reduced ADHD symptoms in children and was well tolerated. SPN-812 may prove to be an effective treatment for children with ADHD. ClinicalTrials.gov identifier: NCT03247530.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Nasser A,Liranso T,Adewole T,Fry N,Hull JT,Chowdhry F,Busse GD,Cutler AJ,Jones NJ,Findling RL,Schwabe Sdoi
10.1016/j.clinthera.2020.05.021subject
Has Abstractpub_date
2020-08-01 00:00:00pages
1452-1466issue
8eissn
0149-2918issn
1879-114Xpii
S0149-2918(20)30283-6journal_volume
42pub_type
杂志文章,随机对照试验abstract:PURPOSE:Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clini...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.10.009
更新日期:2017-12-01 00:00:00
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journal_title:Clinical therapeutics
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doi:10.1016/j.clinthera.2009.11.021
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doi:10.1016/j.clinthera.2018.02.015
更新日期:2018-04-01 00:00:00
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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doi:10.1016/s0149-2918(07)80087-7
更新日期:2007-03-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1990-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2007.03.018
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abstract:BACKGROUND:Reduction in plasma low-density lipoprotein cholesterol (LDL-C) is a fundamental treatment for the prevention of acute coronary syndromes (ACS). Although statin therapy confers significant protection against ACS in both primary and secondary prevention, a considerable residual risk remains after intensive th...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.05.348
更新日期:2017-07-01 00:00:00
abstract::The efficacy and safety of transferring 76 patients with poorly controlled type II diabetes mellitus from various self-mixed human insulin regimens to a premixed insulin regimen (Novolin 70/30, 70% NPH and 30% Regular insulin, semisynthetic) were evaluated in a 24-week, multicenter, open-label study. During the initia...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1994-01-01 00:00:00
abstract::Pediatric patients experience unique differences from the adult population in pharmacokinetic parameters and, consequently, require individualized dosing. Medications useful in pediatric medicine often lack a therapeutic indication and dosing guideline for this population. In addition, the absence of an available pedi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1991-09-01 00:00:00
abstract::Congestive heart failure (CHF) afflicts more than 4.6 million people in the United States and increases at a rate of 400,000 newly diagnosed patients per year. With more than 1.5 million hospital admissions per year attributed to CHF, it is the number one cause of hospitalization. Hospital length of stay (LOS) is one ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:1996-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.05.009
更新日期:2019-08-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.09.006
更新日期:2018-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2006.03.008
更新日期:2006-03-01 00:00:00
abstract:PURPOSE:Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2017-08-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:2001-10-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1983-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2007.04.013
更新日期:2007-04-01 00:00:00
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pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.07.004
更新日期:2007-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:1989-09-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.08.012
更新日期:2015-10-01 00:00:00
abstract::A multicenter, double-blind clinical evaluation of three formulations of betamethasone dipropionate was conducted in 258 patients with severe psoriasis. The results obtained after a standard two-week treatment period clearly indicated that a new glycol preparation produced significantly greater improvement than the oi...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1980-01-01 00:00:00
abstract::A 1-year, open-label extension of a 12-week, double-blind clinical trial was conducted to evaluate the long-term safety and efficacy of once-daily therapy with triamcinolone acetonide nasal aerosol (110, 220, or 440 micrograms) in 93 patients with perennial allergic rhinitis. All three doses of triamcinolone acetonide...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-03-01 00:00:00
abstract:BACKGROUND:Coronary heart disease is the major cause of mortality in individuals with diabetes mellitus (DM). Given the increasingly aggressive low-density lipoprotein cholesterol (LDL-C) goals for patients with DM set by the National Cholesterol Education Program Adult Treatment Panel III and the American Diabetes Ass...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:2004-03-01 00:00:00
abstract:BACKGROUND:Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2011-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:
更新日期:1993-09-01 00:00:00