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NOT YET RECRUITING
NCT06499116
PHASE4

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

View on ClinicalTrials.gov

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

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.