CandeSpartan Study. Candesartan Spanish Response-prediction and Tolerability Study

NCT04138316 | Completed DMC

• 1 other identifier: PI 19-1452
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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 preventive drugs. Patients will receive Candesartan the same manner and intensity if they were not enrolled in the study. Vital signs, clinical variables and adverse events will be monitored. Primary endpoint will be to determine demographic and clinical factors associated with a 50% reduction in the frequency of headache days per month between weeks 20 and 24 compared with baseline.

Conditions

Migraine; Head Pain

Keywords

headache disorders

Outcome Measures

Primary Outcomes (1)

• Response prediction.

  To determine which demographic or clinical variables present at baseline are associated with a 50% reduction in the frequency of headache days per month between weeks 20 to 24 compared with baseline in a regression analysis.

  Weeks 20 to 24 compared with baseline period

Secondary Outcomes (27)

• Response predictors

  Between weeks 20 to 24 compared with baseline period

• Adverse events.

  through study completion, an average of 24 weeks.

• Discontinuation due to adverse events.

  through study completion, an average of 24 weeks.

• 50% response rate at 24 weeks

  Between weeks 20 to 24 compared with baseline period

• 30% response rate at 24 weeks

  Between weeks 20 to 24 compared with baseline period

Study Arms (1)

Migraine patients

Drug: Candesartan

Interventions

Candesartan DRUG

Treatment with Candesartan

Migraine patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with episodic migraine or chronic migraine according to The International Classification of Headache Disorders, receiving Candesartan under the criteria of their physician and according to local guidelines.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario Valladolid

Valladolid, 47003, Spain

Location

Related Publications (10)

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

  PMID: 30879893 BACKGROUND

• Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.

  PMID: 20473702 BACKGROUND

• GBD 2017 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1859-1922. doi: 10.1016/S0140-6736(18)32335-3.

  PMID: 30415748 BACKGROUND

• Pedraza MI, Mulero P, Ruiz M, de la Cruz C, Herrero S, Guerrero AL. Characteristics of the first 2,000 patients registered in a specialist headache clinic. Neurologia. 2015 May;30(4):208-13. doi: 10.1016/j.nrl.2013.12.010. Epub 2014 Jan 30. English, Spanish.

  PMID: 24485650 BACKGROUND

• Evers S, Afra J, Frese A, Goadsby PJ, Linde M, May A, Sandor PS; European Federation of Neurological Societies. EFNS guideline on the drug treatment of migraine--revised report of an EFNS task force. Eur J Neurol. 2009 Sep;16(9):968-81. doi: 10.1111/j.1468-1331.2009.02748.x.

  PMID: 19708964 BACKGROUND

• Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):65-9. doi: 10.1001/jama.289.1.65.

  PMID: 12503978 BACKGROUND

• Stovner LJ, Linde M, Gravdahl GB, Tronvik E, Aamodt AH, Sand T, Hagen K. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. Cephalalgia. 2014 Jun;34(7):523-32. doi: 10.1177/0333102413515348. Epub 2013 Dec 11.

  PMID: 24335848 BACKGROUND

• Garcia-Azorin D, Santos-Lasaosa S, Gago-Veiga AB, Viguera Romero J, Guerrero-Peral AL. Real world preventative drug management of migraine among Spanish neurologists. J Headache Pain. 2019 Feb 15;20(1):19. doi: 10.1186/s10194-019-0971-6.

  PMID: 30770719 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Garcia-Azorin D, Martinez-Badillo C, Camina Muniz J, Gago-Veiga AB, Morollon Sanchez N, Gonzalez-Quintanilla V, Porta-Etessam J, Sierra-Mencia A, Gonzalez-Garcia N, Gonzalez-Osorio Y, Polanco-Fernandez M, Recio-Garcia A, Belvis Nieto R, Guerrero-Peral AL. CandeSpartan Study: Candesartan Spanish Response-prediction and Tolerability study in migraine. Cephalalgia. 2024 Apr;44(4):3331024241248833. doi: 10.1177/03331024241248833.

  PMID: 38663908 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache; Headache Disorders

Interventions

candesartan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 24, 2019
• Study Start: January 2, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

ES (1)