Status:
COMPLETED
CandeSpartan Study. Candesartan Spanish Response-prediction and Tolerability Study
Lead Sponsor:
Hospital Clínico Universitario de Valladolid
Conditions:
Migraine
Head Pain
Eligibility:
All Genders
18+ years
Brief Summary
Observational, prospective, descriptive, open study on response predictors and tolerability of Candesartan in patients \>18 years with episodic or chronic migraine with prior failure of three or more ...
Detailed Description
CandeSpartan Study Candesartan Spanish Response-prediction and Tolerability study Observational study on response predictors and tolerability of Candesartan in usual clinical practice INTRODUCTION: ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of migraine (episodic or chronic) according to the International Classification of headache Disorders (ICHD), 3rd version, criteria10.
- Being treated with Candesartan under the criteria of the physician and according to local guidelines.
- Age \>18 years. More than 4 days of headache per month in the preceding 3 months. More than 1 year of migraine evolution. Beginning of migraine before the age of 50. Ability to provide informed consent.
- Exclusion criteria:
- Previous failure of three or more preventive drugs in accordance with the definition provided below.
- Concomitant use of another preventive drug or use of it in less than 5-half lives of the drug.
- History of another active primary headache with a periodicity considered frequent according to the International Classification of Headache disorders, that is, more than 10 days per month at the time of screening or the basal period.
- Continuous or daily headache in the month prior to inclusion in the study. Pregnancy or breastfeeding. Any relevant cardiovascular conditions. Kidney diseases. Hyperkaliemia. Use of another concomitant preventive. Previous use of candesartan. Current use of another Angiotensin Conversing Enzime Inhibitor or Angiotensin-II receptor antagonist.
- Alcoholism or drug use.
- Concomitant treatment:
- The study will not interfere in the current practice, participants will receive the candesartan in the same manner and intensity if they were not enrolled in the study.
- Patients will be allowed to use their usual symptomatic treatment as usual. The number of days of symptomatic treatment and the number of use of triptans will be reflected.
- The concomitant drugs with potential use as a preventive according to National Clinical Practice guidelines (gabapentin, pregabalin, tricyclic antidepressants, duloxetine, valproic acid, phenytoin, lamotrigine, topiramate, botulinum toxin, anti-CGRP antibodies, beta-blockers, lisinopril) will not be permitted.
- Treatment failure shall be defined as insufficient efficacy at a sufficient dose and for an adequate duration or withdrawal due to adverse effects of a drug present in the national headache guidelines.
Exclusion
Key Trial Info
Start Date :
January 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04138316
Start Date
January 2 2020
End Date
December 16 2022
Last Update
December 19 2022
Active Locations (1)
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1
Hospital Clínico Universitario Valladolid
Valladolid, Spain, 47003