Demographic comparison of subjects in FDA approval trials in the United States to disorder specific demographics using Real World Data.

The Food and Drug Administration (FDA) has recommended that clinical trial study populations accurately reflect the patients likely to use the product, if approved. The FDA has not provided specific guidance on how cohort sizes of clinically relevant demographic characteristics should be determined. Therefore, the present study was designed to compare demographic characteristics reported in US-only FDA approval trials to the demographic characteristics of the related medical disorders in an electronic health records database of >150 M patients in the United States (US).

Real world data analysis of frontotemporal dementia: Implications for future clinical research.

Frontotemporal dementia (FTD) is a progressive decline of cognitive abilities associated with other neuropsychiatric comorbidities. A real-world data (RWD) analysis of a large electronic healthcare records (EHR) database identified the comorbidities of FTD. Deidentified EHRs in the TriNetX Network database from >155,000,000 individuals in the United States established an FTD Cohort (ICD-10 Code G31.

Demographic Analysis of Industry-Sponsored Alzheimer's Disease Trial Populations in the United States.

The Food and Drug Administration has that "sponsors should enroll participants who reflect the characteristics of clinically relevant populations". Recent reports have noted that global Alzheimer's Disease trials have enrolled predominantly White subjects. However, a thorough analysis of industry-sponsored, United States-only Alzheimer's trials has yet to be performed.

Defining demographic cohorts in clinical trial populations using large electronic health records databases.

The Food and Drug Administration (FDA) has stressed the need to ensure that clinical trial study populations accurately reflect the patients likely to use the product, if approved. However, the FDA has not provided specific guidance on how clinically relevant demographic characteristics might be defined. Therefore, the present study was designed to develop a framework that could be used to rapidly identify population demographics for any medical condition.

Clinical trials update 2015: Year in review.

This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies, as well as novel formulations of previously approved therapeutics. The Table summarizes the major therapeutic headache trials that were ongoing at the end of 2015, according to data obtained from both the "ClinicalTrials.

Clinical trials update 2014: year in review.

This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies as well as novel formulations of previously approved therapeutics. Table 1 summarizes the major therapeutic headache trials that were ongoing at the end of 2014, according to data obtained from both the "ClinicalTrials.

What turns on a migraine? A systematic review of migraine precipitating factors.

Migraine attacks rarely occur spontaneously in the absence of any possible precipitating factors. A systematic literature review of 25 publications revealed a consistent set of stimuli that have been identified as factors associated with the onset of a migraine attack. The weighted average of the "Top 10" trigger factors was determined.

Calcitonin gene-related peptide targeted immunotherapy for migraine: progress and challenges in treating headache.

A role for calcitonin gene-related peptide (CGRP) in the pathophysiology of migraine has been established over the past 25 years. There have now been at least five different small-molecule CGRP antagonists that have demonstrated statistical proof of efficacy in the acute treatment of migraine. At present, multiple clinical trials are underway that are assessing the ability of long-acting antibodies against CGRP to prevent frequent migraine attacks.

Clinical trials update. 2013: year in review.

This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies, as well as novel formulations of previously approved therapeutics. Table 1 summarizes the major therapeutic headache trials that are ongoing at the present time, according to data obtained from both the "ClinicalTrials.

2010: year in review.

This section of Headache annually reviews the status of recently completed and ongoing clinical trials involving headache disorders. The review will focus on multicenter trials of new therapies as well as novel formulations of previously approved therapeutics. Table 1 summarizes major migraine therapeutic trials that have been completed recently, according to data obtained from the "ClinicalTrials.

Neurogenic inflammation and migraine: implications for the therapeutics.

Significant recent advances in molecular pharmacology have elucidated the molecular pathways involved in neurogenic inflammation (NI). The release of tachykinins and endothelin-3 (ET-3) from trigeminal neurons induces dural vascular permeability and vasodilatation via activation of tachykinin receptor 1 (Tacr1) and endothelin receptor type B (Ednrb) on endothelial cells. Endothelial cell receptor stimulation results in cellular contraction, leading to plasma protein extravasation (PPE), which is the most recognized physiological hallmark of NI, and nitric oxide-induced vasodilatation.

Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain.

Purpose: The purpose of this single-blind, placebo-controlled, 3-arm parallel, randomized study was to compare the analgesic efficacy and tolerability of a single dose of 100 mg diclofenac potassium (Cataflam; Novartis, Stein, Switzerland), 100 mg diclofenac sodium softgel, and placebo in patients experiencing moderate to severe postoperative pain after third molar extraction.

Patients And Methods: Seventy-five patients (67% female with a mean age of 23, age range 18 to 34.5 years) participated in the study following removal of at least 1 impacted mandibular third molar.

Migraine: a chronic sympathetic nervous system disorder.

Objectives: To determine the degree of diagnostic and clinical similarity between chronic sympathetic nervous system disorders and migraine.

Background: Migraine is an episodic syndrome consisting of a variety of clinical features that result from dysfunction of the sympathetic nervous system. During headache-free periods, migraineurs have a reduction in sympathetic function compared to nonmigraineurs.

Efficacy of diclofenac sodium softgel 100 mg with or without caffeine 100 mg in migraine without aura: a randomized, double-blind, crossover study.

Objective: A phase II, randomized, double-blind, crossover study was designed to evaluate the efficacy of 100-mg diclofenac sodium softgel (formulated using ProSorb technology) with or without 100-mg caffeine versus placebo in migraineurs during migraine attacks.

Background: Diclofenac has been demonstrated to be an effective migraine treatment in several placebo-controlled studies. A rapidly absorbed softgel of diclofenac has been shown to be effective in the rapid relief of acute pain, and may have advantages in migraine treatment.

Glucose regulation in headache: implications for dietary management.

Dietary factors are frequently cited as 'triggers' of migraine and other types of headache. A review of the literature indicates that two specific dietary factors frequently induce headache: fasting and the relatively mild reactive hypoglycemia that can follow large carbohydrate ingestions. The maintenance of serum glucose levels to supply the energy for the nervous system is a primary responsibility of the sympathetic nervous system.

Migraine with aura susceptibility locus on chromosome 19p13 is distinct from the familial hemiplegic migraine locus.

Migraine is a common neurological disease with a major genetic component. Recently, it has been proposed that a single locus on chromosome 19p13 contributes to the genetic susceptibility of both rare familial hemiplegic migraine (FHM) and more common types of migraine, migraine with aura and migraine without aura. We analyzed 16 families for co-segregation of migraine with aura and chromosome 19p13 markers.

Single-nucleotide polymorphism alleles in the insulin receptor gene are associated with typical migraine.

We have identified a migraine locus on chromosome 19p13.3/2 using linkage and association analysis. We isolated 48 single-nucleotide polymorphisms within the locus, of which we genotyped 24 in a Caucasian population comprising 827 unrelated cases and 765 controls.

Analysis of Internet sites for headache.

The Internet is capable of providing an unprecedented amount of information to both physicians and patients interested in headache. To assess the status of headache information on the Internet (as of January 2000), a search for 'headache' was performed using 10 leading Internet search engines. The number of web pages identified ranged from 4419 (WebCrawler) to 506 426 (Northern Light).

The value of genotyping for apolipoprotein E alleles in relation to vitamin E supplementation.

The clinical utility of genotyping individuals for apolipoprotein E alleles remains controversial. The present summary reviews clinical and scientific data that suggest that vitamin E supplementation may be beneficial in individuals who carry the apolipoprotein E4 allele. We propose that early anti-oxidant intervention with vitamin E supplementation may have life-long beneficial effects for individuals who carry one or more apolipoprotein E4 alleles.