NCT06499116

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Topiramate	Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.
DRUG	Flunarizine	Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.
DRUG	Amitriptyline	Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.
DRUG	Propranolol	Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-12
• Last updated: 2024-07-12