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Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Summary
This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.
Official title: Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2024-10
Completion Date
2026-12
Last Updated
2024-07-12
Healthy Volunteers
No
Conditions
Interventions
Topiramate
Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.
Flunarizine
Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.
Amitriptyline
Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.
Propranolol
Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.