Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study.

Background Safety findings from a Phase 2b study of galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, for prevention of migraine (NCT02163993) are reported here. Methods Patients aged 18-65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study. After randomization, 410 patients were administered 5, 50, 120 or 300 mg of galcanezumab or placebo subcutaneously once every 4 weeks for 12 weeks, followed by a post-treatment off-drug period lasting 12 weeks.

Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial.

Objective: To assess fall events in older depressed patients during treatment with duloxetine.

Method: Post hoc analysis of solicited fall events collected at each study visit using a questionnaire during a 24-week, multicenter, randomized, placebo-controlled, double-blind, phase 4 trial (November 2006 to November 2009). Older outpatients (≥ 65 years) with major depressive disorder (DSM-IV criteria) were randomly assigned to duloxetine 60 mg/d (n = 249) or placebo (n = 121) for the 12-week acute phase, after which the duloxetine dose could be increased to 120 mg/d and nonresponding placebo patients could be switched to duloxetine 60 mg/d.

Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol.

Objective: Return of functional ability is a central goal in the treatment of major depressive disorder. We conducted two trials with the same protocol that was designed to assess functioning after 8 Weeks of treatment with duloxetine.

Methods: The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities).

Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials.

Objective: Summarize safety and tolerability of duloxetine in treating diabetic peripheral neuropathic pain.

Research Design And Methods: Pooled data from three double-blind, randomized studies with 12-week, placebo-controlled (acute) and 52-week, routine-care-controlled (extension) phases.

Main Outcome Measures: Frequency/discontinuations due to treatment-emergent adverse events (TEAEs).