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Otsuka Pharmaceutical Co., Ltd. (Otsuka) 1xbet 카지노 H. Lundbeck A/S (Lundbeck) announce top-line results from two phase III clinical trials evaluating the efficacy, safety 1xbet 카지노 tolerability of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type.
The primary endpoint of both trials was change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess the symptoms of agitation. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI S) score, a 7-point scale assessing overall severity of the patient's agitation. These studies were conducted in multiple countries in North America 1xbet 카지노 Europe, 1xbet 카지노 in the Russian Federation.
In both studies, patients treated with brexpiprazole showed improvements in symptoms of agitation relative to placebo. In the first study, the improvement in the primary endpoint of CMAI for 2 mg brexpiprazole was statistically better than placebo (p<0.05) 1xbet 카지노 appeared more robust than the improvements on the key secondary endpoint of CGI-S (p0.05). In the second study, the improvements in the primary endpoint of CMAI (p0.05) appeared less robust than improvements observed on the key secondary endpoint of CGI-S (p<0.05). In both studies, there was variability in the data from different countries, perhaps associated with differing st1xbet 카지노ards of care; the data from Russian sites showed especially poor separation between placebo 1xbet 카지노 drug.
Regarding safety 1xbet 카지노 tolerability, both studies confirmed the profile of brexpiprazole as observed in the clinical trials for schizophrenia 1xbet 카지노 for adjunctive treatment of major depressive disorder (MDD). The most common adverse events in patients receiving brexpiprazole versus placebo (incidence 3% 1xbet 카지노 greater than placebo) were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), 1xbet 카지노 somnolence (3.3% vs. 2.2%). Overall mortality during the studies was 0.86% 1xbet 카지노 none of the deaths were considered to be related to treatment.
About 1xbet 카지노 studies
Both trials were r1xbet 카지노omized, double-blind, placebo-controlled phase III studies that enrolled a combined total of approximately 700 participants. Trial participants were between 51 1xbet 카지노 90 years of age with a diagnosis of probable Alzheimer's disease 1xbet 카지노 symptoms of agitation. Both outpatients 1xbet 카지노 patients living in institutionalcare settings were included in the trials. One of the trials studied fixed doses of either 1 or 2 mg per day of brexpiprazole or placebo, while the other trial studied a flexible-dose range of 0.5 mg, 1 mg or 2 mg per day of brexpiprazole, or placebo. Both trials were 12-weeks in duration.
1xbet 카지노 companies plan to meet with 1xbet 카지노 FDA to discuss 1xbet 카지노 results of 1xbet 카지노 studies. 1xbet 카지노 results will be presented in scientific congresses over 1xbet 카지노 next year.
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