Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study.

Introduction: This analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM).

Methods: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months' (primary) or 12/18 months' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months' post-treatment follow-up.

Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial.

Background: The objective of this analysis was to gain new insights into the patient characteristics and other factors associated with lasmiditan usage and clinical outcomes under conditions resembling the real-world setting.

Methods: This was a post hoc analysis of data from the 12-month, open-label extension (OLE) of the phase 3, double-blind, randomized, controlled CENTURION trial, which examined the efficacy and safety of lasmiditan as acute treatment across four migraine attacks. Patients completing the main study who treated ≥ 3 attacks could continue in the OLE.

Galcanezumab Efficacy Through the Dosing Interval in Japanese Patients with Episodic Migraine: Post Hoc Analysis of a Phase 2 Randomized Trial.

Introduction: The efficacy and safety of galcanezumab as a preventive treatment in Japanese patients with episodic migraine was demonstrated in a phase 2, randomized, placebo-controlled trial (conducted December 2016-January 2019). This post hoc analysis assessed the consistency of galcanezumab efficacy through the monthly dosing interval.

Methods: Patients with 4-14 migraine headache days/month were randomized (2:1:1, stratified by baseline migraine frequency) to subcutaneous placebo (n = 230), 120-mg galcanezumab (with 240-mg loading dose; n = 115) or 240-mg galcanezumab (n = 114) once monthly for 6 months.

Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study.

Background: Migraine is often comorbid with other disorders. People with migraine may be prescribed one or more concomitant medications. This post hoc analysis assessed the safety and efficacy of lasmiditan in Japanese people with migraine comorbidities or using concomitant medications.

Efficacy of Lasmiditan Across Patient and Migraine Characteristics in Japanese Patients with Migraine: A Secondary Analysis of the MONONOFU Trial.

Introduction: This MONONOFU trial subgroup analysis evaluates the efficacy of lasmiditan across patient and migraine characteristics in Japanese patients with migraine.

Methods: MONONOFU trial was a multicenter, randomized, double-blind, placebo-controlled study. The patients were randomly assigned in a 3:7:6:7 ratio to receive lasmiditan 50 mg, 100 mg, 200 mg, or placebo for a single migraine attack within 4 h of pain onset.

Rapid Onset and Sustained Efficacy of Lasmiditan Among Japanese Patients with Migraine: Prespecified Analyses of a Randomized Controlled Trial.

Introduction: Rapid onset and sustained efficacy are important for acute migraine treatment. Global phase 3 trials have demonstrated the early onset and sustained efficacy of the 5-HT receptor agonist lasmiditan. In this prespecified analysis of the MONONOFU study, we assessed the onset and sustained efficacy of lasmiditan in Japanese patients with migraine.

Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial.

Background: Some migraine treatments are contraindicated for patients with cardiovascular disease (CVD) or risk factors (CVRFs). We report safety and efficacy of lasmiditan, a new oral acute migraine treatment with no cardiovascular contraindication, in Japanese patients with CVRFs.

Research Design And Methods: MONONOFU was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Japanese patients with migraine (met International Headache Society criteria, Migraine Disability Assessment score ≥11, disabling migraine for ≥1 year).

Safety profile of lasmiditan in patients with migraine in an Asian population.

Background: MONONOFU, a multicenter, randomized, double-blind, placebo-controlled phase 2 study of Japanese patients with migraine, was pivotal for lasmiditan approval in Japan. However, treatment-emergent adverse events (TEAEs) were more common than in global studies. A detailed safety profile would assist patient management.

Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients.

Objective: To evaluate the efficacy and safety of lasmiditan in Japanese adults with migraine.

Background: Global clinical studies have demonstrated the efficacy and safety of lasmiditan in the acute treatment of migraine.

Methods: This was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study in Japan (NCT03962738), which enrolled adults with migraine with or without aura.

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia.

Objective: To assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM) in patients with acute agitation associated with schizophrenia in a real-world clinical setting.

Methods: The postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study). Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration.

Safety and effectiveness of rapid-acting intra-muscular olanzapine for agitation associated with schizophrenia - Japan postmarketing surveillance study.

Objective: The objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM) olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.

Methods: In this multicenter, postmarketing surveillance (PMS) study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration.

Perceptions and impact of bipolar disorder in Japan: results of an Internet survey.

Bipolar disorder is a recurrent and episodic illness. This survey study assessed experiences and identified clinical insights of individuals with bipolar disorder. An Internet-based monitor system database was screened for patients with bipolar disorder in Japan (February and March 2013).

Antipsychotic monotherapy among outpatients with schizophrenia treated with olanzapine or risperidone in Japan: a health care database analysis.

Purpose: Antipsychotic monotherapy is often recommended over antipsychotic polypharmacy because of fewer adverse events, reduced treatment complexity, and lower medication cost. This study compared the rate and the duration of antipsychotic monotherapy following initiation of olanzapine or risperidone in the treatment of outpatients with schizophrenia in Japan.

Methods: Outpatients diagnosed with schizophrenia in the Japan Medical Data Center database were identified using International Statistical Classification of Diseases and Related Health Problems, 10th Revision, diagnosis codes.

Predictors of antipsychotic monotherapy with olanzapine during a 1-year naturalistic study of schizophrenia patients in Japan.

Purpose: Although expert guidelines for the treatment of schizophrenia recommend antipsychotic monotherapy, the use of antipsychotic polypharmacy is common. This study identified characteristics that differentiate patients with schizophrenia who are treated with olanzapine monotherapy versus polypharmacy in usual care in Japan.

Patients And Methods: In a large (N = 1850) prospective, observational study, Japanese patients with schizophrenia who initiated treatment with olanzapine were followed for 1 year.

Predictors of continuation with olanzapine during the 1-year naturalistic treatment of patients with schizophrenia in Japan.

Purpose: Treatment continuation is considered an important measure of antipsychotic effectiveness in schizophrenia, reflecting the medication's efficacy, safety, and tolerability from both patients' and clinicians' perspectives. This study identified characteristics of patients with schizophrenia who continue olanzapine therapy for a 1-year period in Japan.

Methods: In a large (N = 1850), prospective, observational study, Japanese patients with schizophrenia who initiated treatment with olanzapine were followed for 1 year.