Refractory chronic migraine
Conditions
Interventions
Trade Name: Diprivan 1%
Pharmaceutical Form: Emulsion for injection/infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Current Sponsor code: 58785
Other descriptive name: Diprivan
Concentrat
Sponsors
Hospital General Universitario de Alicante
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the analgesic efficacy of Diprivan ® infusion in the prevention of migraine refractory to medical therapy.;Secondary Objective: To assess the tolerability and safety of the infusion of Diprivan® in the prevention of migraine refractory to treatment. -Reduction in the mean frequency of migraine attacks at 6 months after initiation of study treatment compared to baseline. responders. -Number of days with migraine per month of treatment.-half intensity of headache attacks during each month of follow-up (VAS) . - Speed effect in reducing the frequency of attacks by comparing the frequency of attacks per month of Treatment. -Consumption of medication for acute treatment accounted mensual. -Evaluation of the patient's subjective improvement through quality of life test of migraine. -Assessment of disability caused by migraine using the MIDAS questionnaire.;Primary end point(s): Reduction in the average frequency of migraine attacks per month and 3 months after initiation of study treatment compared to baseline.;Timepoint(s) of evaluation of this end point: Month and three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Reduction in the average frequency of migraine attacks at 6 months after initiation of study treatment on the situation respondedores. basal.-Number of days with migraine per month of Treatment.-Intensity of headache average during attacks per month of follow-up [Scale categorical and VAS] .- Speed effect in reducing the frequency of attacks, by comparing the frequency of attacks per month of treatment.-Medication consumption acute treatment accounted monthly.-Evaluation of the patient's subjective improvement through Quality of Life Test related migraine.-Assessment of disability caused by migraine using the MIDAS questionnaire.;Timepoint(s) of evaluation of this end point: Month, 3 months and at 6 months. | — |
Countries
Spain
Contacts
Public ContactFundación Investigación (HGUA)
Hospital General Universitario de Alicante (HGUA)
Outcome results
None listed