Pilot, placebo-controlled, double-blind, randomized, parallel propofol effective in preventing refractory chronic migraine

Hospital General Universitario de Alicante0 个研究点目标入组 70 人开始时间: 2011年11月22日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•1.18-65 years old (inclusive), at the time of study inclusion, and can be of any race or sex.2. Age of onset of migraine under 50.3.Free acceptance of trial participation, with written informed consent.4.Ability to properly complete the registration data to assess.5.Diagnostic criteria for chronic migraine according to IHS: * Migraine without aura that occurs 15 days / month for> 3 months in the absence of medication overuse and not attributable to other disorders. * Besides the headache is a disorder that manifests as recurrent attacks that last 4-72 5 hours and has 2 of the following features:- unilateral location; pulsatile-quality, moderate or severe-intensity;-aggravated or improved by avoiding routine physical activities, and during the headache, 1 of the following:-nausea and / or vomiting, photophobia and prophylactic fonofobia.6.Prophilactic medicación unchanged in the last 3 months prior to inclusión.7.If you have left of prophylactic medication must have spent> 1 month to ensure a sufficient washout period for drugs with long elimination half-life.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Women in the period of pregnancy or nursing women and suspected in the probability of pregnancy by history data. 2.Patients without prophylactic medication for migraine or it has started less than three months. 3.Allergy to either drug, including its excipients (soy, peanut, egg) and allergy to fat emulsions. 4.Patients with hypertriglyceridemia (> 150 mg / dl) .5. Patients who do not meet the IHS criteria (ICHD-IIR1) .6. Patients with serious hepatic impairment who received propofol.7.Patients in the 6 months prior to entry into the study.8.Patients with severe renal insufficiency (creatinine> 3 mg / dl) .9. Patients with cronic pancreatitis. with poor venous access crónica.10.Pacientes periférico.11.Patients with poor peripheral venous access. 12.Patients with diminished capacity to give informed consent.13.Familiares of staff involved in the research.

发起方

Hospital General Universitario de Alicante