Efficacy, Safety and Tolerability of Tavapadon (PF-06649751) in Subjects With Early Stage Parkinson’s Disease: A Randomized, Placebo-Controlled Trial

On Monday, 23 September, the Tavapadon team presented a poster highlighting the Tavapdon Phase 2 study data in early Parkinson's Disease at the International Congress of Parkinson’s Disease and Movement Disorders in Nice, France.  Download the poster below. Objective: To evaluate the efficacy and safety of tavapadon (formerly known as PF-06649751) in subjects with early [...]

2019-09-30T21:25:16+00:00September 23rd, 2019|Publications|

First Clinical Translation of the Anti-Nociceptive/Anti-Hyperalgesic Efficacy of a T-Type Calcium Channel Modulator (Z944) Using Laser Evoked Potentials and VAS in UV-B and Capacian Irritated Skin in Healthy Humans

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 [...]

2017-02-22T16:04:34+00:00October 1st, 2014|Publications|

CSF and Plasma Monoamine Profile of the Triple-Reuptake Inhibitor SEP-432 in Healthy Volunteers

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 [...]

2017-02-22T16:04:35+00:00May 5th, 2014|Publications|

ALZ-801, a Novel Prodrug of Tramiprosate Which Improves Cognition and Function in ApoE4-Positive Alzheimer’s Disease Patients

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 [...]

2017-02-22T16:04:35+00:00March 20th, 2014|Publications|

Tolerability of Oral Ziprasidone in Children and Adolescents with Bipolar Mania, Schizophrenia, or Schizoaffective Disorder

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 [...]

2017-02-22T16:04:35+00:00November 5th, 2008|Publications|

Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: A randomized, double-blind study

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 [...]

2017-02-22T16:04:35+00:00July 16th, 2007|Publications|

The AMPA Antagonist ZK 200775 in Patients with Acute Ischaemic Stroke: A Double-Blind, Multicentre, Placebo-Controlled Safety and Tolerability Study

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 [...]

2017-02-22T16:04:35+00:00August 30th, 2005|Publications|

Concentration-Effect Relationships of Alcohol in a Computerised Psychometric Test System

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 [...]

2017-02-22T16:04:35+00:00January 1st, 2005|Publications|

Efficacy and tolerability of twice- daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial

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 [...]

2017-02-22T16:04:35+00:00January 5th, 2004|Publications|

Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial

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 [...]

2017-02-22T16:04:35+00:00January 5th, 2004|Publications|
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