MedTrace Logo

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

NCT06499116 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2024-07-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-12-31
Completion
2026-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499116 on ClinicalTrials.gov