A5011281487- Statistical Methods in Clinical Trials
- Migraine and Headache Studies
- Trigeminal Neuralgia and Treatments
- Statistical Methods and Inference
- Health Systems, Economic Evaluations, Quality of Life
- Schizophrenia research and treatment
- Treatment of Major Depression
- Sympathectomy and Hyperhidrosis Treatments
- Electroconvulsive Therapy Studies
- Dementia and Cognitive Impairment Research
- Machine Learning in Healthcare
- Healthcare Decision-Making and Restraints
- Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Neural Networks and Applications
- Tryptophan and brain disorders
- Meta-analysis and systematic reviews
- Functional Brain Connectivity Studies
- Psychosomatic Disorders and Their Treatments
- Advanced Causal Inference Techniques
- Optimal Experimental Design Methods
- Acute Myocardial Infarction Research
- Bayesian Methods and Mixture Models
- Face and Expression Recognition
- Statistical Methods and Bayesian Inference
- Psychiatric care and mental health services
Otsuka (Japan)
2012-2025
Teva Pharmaceuticals (United States)
2021
The Graduate University for Advanced Studies, SOKENDAI
2021
Abstract Objective To determine the efficacy and safety of fremanezumab administration in Japanese Korean patients with chronic migraine (CM). Background Available preventive treatments for CM are limited by various issues. Fremanezumab, a monoclonal antibody that targets calcitonin gene‐related peptide pathway involved pathogenesis, has been shown to be effective well tolerated large‐scale, international Phase 3 trials. Methods Randomized, placebo‐controlled trial who received subcutaneous...
To evaluate the efficacy and safety of two dosing regimens fremanezumab in Japanese Korean patients with episodic migraine.
Abstract Background Multivariable prediction models are important statistical tools for providing synthetic diagnosis and prognostic algorithms based on patients’ multiple characteristics. Their apparent measures predictive accuracy usually have overestimation biases (known as ‘optimism’) relative to the actual performances external populations. Existing evidence guidelines suggest that three bootstrap-based bias correction methods preferable in practice, namely Harrell’s .632 .632+...
Abstract In assessing prediction accuracy of multivariable models, optimism corrections are essential for preventing biased results. However, in most published papers clinical the point estimates measures corrected by adequate bootstrap‐based correction methods, but their confidence intervals not corrected, example, DeLong's interval is usually used C ‐statistic. These naïve methods do adjust bias and account statistical variability estimation parameters models. Therefore, coverage...
Abstract INTRODUCTION We evaluated the efficacy and safety of brexpiprazole for treatment agitation in Alzheimer's dementia (AAD) Japanese patients. METHODS This was a phase 2/3 multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. Patients with AAD were randomized to receive 1 mg/day or 2 mg/day, placebo (3:4:4) 10 weeks. RESULTS For primary endpoint (change Cohen‐Mansfield Agitation Inventory [CMAI] total score from baseline Week 10), both mg groups demonstrated...
Background The long-term safety and efficacy of brexpiprazole in Asian patients with agitation associated dementia due to Alzheimer's disease are unknown. Objectives To evaluate the 14-week treatment 1 or 2 mg/day Japanese who completed 10-week double-blind period a parent phase 2/3 study, explore brexpiprazole. Methods This was 3 multicenter, open-label study (ClinicalTrials.gov Identifier NCT03724942, registered on 28 October 2018). Patients had placebo, were rolled over into this extended...
Inadequate antidepressant response interrupts effective treatment of major depressive disorder (MDD). The BLESS study evaluates the dosage, efficacy, and safety brexpiprazole adjunctive therapy in Japanese patients with inadequate (ADT) response.
Inadequate response to antidepressant monotherapy is common among patients with major depressive disorder (MDD). The efficacy and safety of adjunctive brexpiprazole 2 mg/day has recently been confirmed during the 6-week, randomized, placebo-controlled phase 2/3 (BLESS) study, which evaluated at 1 versus placebo as therapy therapies in 740 Japanese MDD an inadequate monotherapy. This study long-term fixed-dose MDD. An open-label, 52-week enrolled rollover who completed double-blind, BLESS...
Early discontinuation and poor adherence are common limitations of conventional preventive migraine medications that limit their long-term efficacy. Therefore, a medication with favorable safety is warranted. This study aimed to evaluate the tolerability fremanezumab for treatment chronic or episodic in Japanese patients. In this 52-week, randomized, open-label, parallel-group study, monthly quarterly was administered newly enrolled patients migraine. Safety assessed by monitoring...
Abstract Objective To describe exploratory endpoints from a previous phase 2b/3 placebo‐controlled trial conducted in Japan and Korea, specifically investigating the effect of fremanezumab or placebo on migraine‐associated symptoms acute headache medication use patients with episodic migraine (EM). Background EM is associated non‐head pain symptoms, including nausea, vomiting, photophobia, phonophobia, which contribute substantially to disease burden, healthcare resource utilization,...
To evaluate quality of life (QoL) endpoints from two 12-week trials investigating fremanezumab efficacy and safety in Japanese/Korean patients with chronic (CM) or episodic (EM) migraine.Migraine is a leading cause disability affects QoL considerably, interfering work daily activities, social family life, emotional wellbeing.This planned exploratory analysis used data multicenter, randomized, double-blind, placebo-controlled, parallel-group studies which Migraine-Specific (MSQoL; Role...
This paper considers the feed-forward neural network models for data of mutually exclusive groups and a set predictor variables. We take into account bootstrapping based on information criterion when selecting optimum number hidden units model deviance in order to summarize measure goodness-of-fit fitted models. The is also adapted provide estimates bias excess error prediction rule constructed with training samples. Simulated from known (true) are analyzed interpret results using network....