Introduction The primary objective of this study was to investigate the acute anti-nociceptive/anti-hyperalgesic efficacy of Z944, a small-molecule, piperidine-based T-type calcium channel blocker efficacious in preclinical pain models, on Peak-to- Peak (PtP) amplitude reduction of Laser (radiant-heat) evoked potentials (LEPs) from Vertex-EEG compared to placebo in UV-B-inflamed and in capsaicin-irritated skin. Conclusion T-type calcium channels [...]

Abstract Background Based on in-vitro binding studies, SEP-432 is a triple monoamine reuptake inhibitor with a binding affinity for NE>5HT>DA. We determined the maximal tolerated dose (MTD) of SEP-432 to be 300mg/day, and in this study characterized its monoamine profile compared with duloxetine and placebo. Methods Eighteen healthy male and female subjects ages 18-50 [...]

Introduction: ALZ-801 is a novel, orally available small molecule prodrug of tramiprosate with improved pharmaceutical properties. Tramiprosate was advanced to a ~2,000 patient Phase 3 program which completed in 2007, and was deemed inconclusive by the FDA. Subsequent post-hoc analyses of ApoE4 positive patients (n=599) showed that tramiprosate produced a significant and clinically meaningful improvement [...]

Abstract Objective This study characterizes the tolerability of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder. Method Sixty-three subjects (aged 10–17 years) entered an open-label study consisting of a 3-week fixed-dose period (Period 1) and a subsequent 24-week flexible-dose period (Period 2). In Period 1, subjects received ziprasidone 80 or [...]

Abstract Seven published, randomized, placebo-controlled clinical trials with pregabalin have shown robust efficacy for relief of neuropathic pain from DPN and PHN. An investigation of the efficacy and safety of twice daily pregabalin enrolled 395 adults with pain- ful DPN for P1 year in a 12-week, double-blind, placebo-controlled trial. Patients [...]

Abstract Background and Purpose ZK 200775 is a selective competitive AMPA receptor antagonist. It has demonstrated neuroprotective efficacy in experimental models of stroke and tolerability in healthy volunteers. We tested the safety and tolerability of ZK 200775 in patients with acute ischaemic stroke. Methods In a multicentre double-blind, randomised, placebo-controlled phase II trial, 61 ischaemic [...]

Summary The purpose of this study was to validate a computerised psychometric test system by demonstrating the change of the test variables of the Bochum Diagnostic System after administration of alcohol. Twenty-four healthy young male or female volunteers participated in a double- blind, randomised, placebo-controlled study in a 3-way cross-over [...]

Objective This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro­pathic pain associated with postherpetic neuralgia (PHN). Research design and methods The 13­week, double­ blind, placebo-­controlled study randomized 370 patients with PHN to pregabalin (150, 300, or 600 mg/day BID) or placebo. Main outcome [...]

Abstract This study was designed to assess the efficacy and safety of pregabalin—a novel a2-d ligand with analgesic, anxiolytic, and anticonvulsant activity—for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, double-blind, placebo-controlled trial to receive 150 ðn 1⁄4 81Þ; 300 mg/day ðn 1⁄4 [...]

Abstract Information from patients who are unable to continue their visits to a study centre may be of major importance for the interpretation of results in multiple sclerosis (MS) clinical trials. To validate a questionnaire based on the Expanded Disability Status Scale (EDSS), patients in five different European centres were [...]