Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
NCT Number: NCT06499116
Acronym: PREMI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Migraine
Interventions: DRUG: Topiramate|DRUG: Flunarizine|DRUG: Amitriptyline|DRUG: Propranolol
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators: Institut Català de la Salut|Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 460
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-12

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.

Primary Outcome Measures: To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol., Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline., 12 weeks
Secondary Outcome Measures: Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline), Proportion of patients responding at 12 weeks from start of treatment; \<25% change in mean number of MMD: non-responders, 25-49%: partial responders, 50-75%: responders, \>75%: excellent responders., 12 weeks|Evaluate effectiveness before completing the clinical trial, Change in mean number of MMDs at 4 and 8 weeks from baseline., 4, 8 and 12 weeks|Estimate the reduction in the intensity of migraine attacks, Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment., 4, 8 and 12 weeks|Estimate the prevalence of symptoms associated with migraine, Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea., 12 weeks|Evaluate adherence to preventive treatment, Proportion of adherent and non-adherent patients (according to taking \[yes/no\] of the study treatment with the prescribed dosage) at 12 weeks from the start of treatment., 12 weeks|Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others)., Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline., 4, 8 and 12 weeks|Evaluate reconsultation visits due to migraine attacks, Reconsultations: Type of consultation (PCC, PC emergency, hospital, hospital emergency). Number of consultations after 12 weeks from the start. Number of medical tests performed relacionadas con la migraña., 4, 8 and 12 weeks|Evaluate improvement in quality of life and patient satisfaction, Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Including Visual Analogue Scale (0-100). Lower scores means worse health condition., 12 weeks|Analyze the differences between men and women regarding study drugs effectiveness., Result comparison change in mean number of MMDs adjusted by sex, 4, 8 and 12 weeks|Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism., Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment., 12 weeks|Incidence of adverse events of the four drugs used in the preventive treatment of migraine ., Number of adverse events, 12 weeks